Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-28 @ 2:13 PM
Study NCT ID:
NCT04308304
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2020-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 42 days', 'description': 'All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-1942 8 mg BID 7 Days', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 13, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MK-1942 15 mg BID 7 Days', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK-1942 30 mg Bid 7D', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MK-1942 50 mg BID & Days', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MK-1942 Total', 'description': 'Participants received MK-1924 8 mg, 15 mg, 30 mg, and 50 mg during Weeks 1, 2, 3, and 4, respectively.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 18, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo Bid', 'description': 'Participants received placebo + donepezil for 7 days.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Scleral hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Scleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Medical device site injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Electrocardiogram T wave biphasic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With ≥1 Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo + Donepezil AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 42', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing From Study Therapy Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg AD', 'description': 'Participants with AD received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg AD', 'description': 'Participants with AD received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg AD', 'description': 'Participants with AD received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg AD', 'description': 'Participants with AD received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'The number of participants with clinically significant 12-lead ECGs is presented. Recordings were made throughout the study, with the participant in a semi-recumbent position having rested in this position for at least 10 minutes beforehand.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal (Impaired) Results on Targeted Neurological Exams', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 29 days', 'description': 'The number of participants with abnormal (impaired) results on targeted neurological exams will be presented. The targeted neurological exam contains Modules 1, 2 and 5 of the general examination, focusing on arousal, cranial nerve function, and gait and will be administered several times throughout the treatment period starting on Day 1 up until Day 29. The number of participants with abnormal (impaired) results on targeted neurological exams will be reported. Each exam will be graded as Normal or Impaired with the abnormality described.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Suicidal Ideation and/or Behavior on Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': "The number of participants with suicidality using the C-SSRS is presented. The C-SSR will be used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. C-SSRS assessment will be based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale. Suicidal ideation and/or behaviors identified on the C-SSRS may not be considered an adverse event, based on the investigator's judgment. Participants who report at least one occurrence of suicidal behavior or suicidal ideation will be counted as having experienced suicidality. Suicidal behavior includes suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation include a wish to die or active suicidal thought with or without method, intent or plan.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.27', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '1.65', 'groupId': 'OG001'}, {'value': '6.14', 'spread': '2.27', 'groupId': 'OG002'}, {'value': '0.21', 'spread': '2.81', 'groupId': 'OG003'}, {'value': '-4.53', 'spread': '1.06', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdose', 'description': 'The mean change from baseline in HR is presented. Change in HR was determined the first day of treatment with a new dose of MK-1942. A negative value indicates a decrease in HR relative to baseline, and a positive value indicates an increase.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.48', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '0.88', 'spread': '2.09', 'groupId': 'OG002'}, {'value': '1.45', 'spread': '2.19', 'groupId': 'OG003'}, {'value': '5.93', 'spread': '4.00', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdose', 'description': 'The mean change from baseline in SBP is presented. Change in SBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in SBP relative to baseline, and positive values represent an increase.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '1.51', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '1.39', 'groupId': 'OG003'}, {'value': '-1.73', 'spread': '3.36', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdose', 'description': 'The mean change from baseline in DBP is presented. Change in DBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in DBP relative to baseline, and positive values represent an increase.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Chemistry Test Results Reported as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal chemistry-related AEs is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Hematology Test Results Reported as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal hematology-related AEs is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Urinalysis Results Reported as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg', 'description': 'Participants received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg', 'description': 'Participants received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}, {'id': 'OG004', 'title': 'Placebo AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with an abnormal urinalysis results AE is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment are included.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to 12 Hours Postdose (AUC0-12) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg + Donepezil AD', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '1760', 'groupId': 'OG000', 'lowerLimit': '1390', 'upperLimit': '2240'}, {'value': '3580', 'groupId': 'OG001', 'lowerLimit': '2860', 'upperLimit': '4490'}, {'value': '6650', 'groupId': 'OG002', 'lowerLimit': '5330', 'upperLimit': '8280'}, {'value': '11600', 'groupId': 'OG003', 'lowerLimit': '9110', 'upperLimit': '14700'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.69', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.86', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.82', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.00', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.05', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 PK Alone'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'AUC0-12 is reported for the first day of treatment of each MK-1942 dose.', 'unitOfMeasure': 'hr*nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'AUC From Dosing to 24 Hours Postdose (AUC0-24) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg + Donepezil AD', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '3530', 'groupId': 'OG000', 'lowerLimit': '2790', 'upperLimit': '4470'}, {'value': '7160', 'groupId': 'OG001', 'lowerLimit': '5710', 'upperLimit': '8970'}, {'value': '13330', 'groupId': 'OG002', 'lowerLimit': '10700', 'upperLimit': '16600'}, {'value': '23200', 'groupId': 'OG003', 'lowerLimit': '18200', 'upperLimit': '29500'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.69', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.86', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.82', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.00', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.05', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 PK Alone'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'AUC0-24 is reported for the first day of treatment of each MK-1942 dose. Due to twice daily dosing, AUC0-24 was calculated as "AUC0-24 = AUC0-12 x 2".', 'unitOfMeasure': 'hr*nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg + Donepezil AD', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000', 'lowerLimit': '184', 'upperLimit': '310'}, {'value': '477', 'groupId': 'OG001', 'lowerLimit': '371', 'upperLimit': '613'}, {'value': '876', 'groupId': 'OG002', 'lowerLimit': '731', 'upperLimit': '1050'}, {'value': '1360', 'groupId': 'OG003', 'lowerLimit': '1080', 'upperLimit': '1720'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.67', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.87', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.87', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.06', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.08', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 PK Alone'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Cmax is reported for the first day of treatment of each MK-1942 dose.', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration (Ctrough) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg + Donepezil AD', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000', 'lowerLimit': '79.7', 'upperLimit': '127'}, {'value': '228', 'groupId': 'OG001', 'lowerLimit': '188', 'upperLimit': '277'}, {'value': '386', 'groupId': 'OG002', 'lowerLimit': '282', 'upperLimit': '527'}, {'value': '693', 'groupId': 'OG003', 'lowerLimit': '528', 'upperLimit': '910'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.62', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.80', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.81', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.93', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 Alone PK'}, {'groupIds': ['OG003'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.98', 'groupDescription': "'MK-1942 Alone PK' are unpublished data from MK-1942-004", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'MK-1942 + Donepezil PK / MK-1942 PK Alone'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Ctrough is reported for the first day of treatment of each MK-1942 dose. Data from healthy elderly participants used for statistical analyses are unpublished findings from study MK-1942-004.', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 8 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 8 mg + donepezil during Week 1.'}, {'id': 'OG001', 'title': 'MK-1942 15 mg + Donepezil AD', 'description': 'Participants with AD received MK-1942 15 mg + donepezil during Week 2.'}, {'id': 'OG002', 'title': 'MK-1942 30 mg + Donepezil AD', 'description': 'Participants received MK-1942 30 mg + donepezil during Week 3.'}, {'id': 'OG003', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '3.00'}, {'value': '1.98', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '5.95'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.93', 'upperLimit': '3.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Tmax is reported for the first day of treatment of each MK-1942 dose.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Plasma Half-Life (t½) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '27.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 't½ is reported for MK-1942 50 mg.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'Apparent Clearance at Steady-state (CLss/F) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '45.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'CLss/F is reported for MK-1942 50 mg.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution at Steady State (Vzss/F) of MK-1942', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1942 50 mg + Donepezil AD', 'description': 'Participants received MK-1942 50 mg + donepezil during Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '449', 'spread': '41.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Vzss/F is reported for MK-1942 50 mg.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Donepezil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil Day -1', 'description': 'Participants received donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).'}, {'id': 'OG001', 'title': 'Donepezil Day 28', 'description': 'Participants received donepezil in combination with MK-1942 for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '606', 'spread': '66.4', 'groupId': 'OG000'}, {'value': '919', 'spread': '44.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean', 'paramValue': '1.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '52.4', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Donepezil Accumulation Ratio (Day 28/Day -1)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'AUC0-24 is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28). Due to twice daily dosing, AUC0-24 was calculated as "AUC0-12 x 2".', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available."}, {'type': 'SECONDARY', 'title': 'Cmax of Donepezil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil Day -1', 'description': 'Participants received donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).'}, {'id': 'OG001', 'title': 'Donepezil Day 28', 'description': 'Participants received donepezil in combination with MK-1942 for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '56.4', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '42.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean', 'paramValue': '1.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '52.4', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Donepezil Accumulation Ratio (Day 28/Day -1)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Cmax is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available."}, {'type': 'SECONDARY', 'title': 'Ctrough of Donepezil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil Day -1', 'description': 'Participants received donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).'}, {'id': 'OG001', 'title': 'Donepezil Day 28', 'description': 'Participants received donepezil in combination with MK-1942 for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '72.7', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '52.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean', 'paramValue': '1.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '60.8', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Donepezil Accumulation Ratio (Day 28/Day -1)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Ctrough is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available."}, {'type': 'SECONDARY', 'title': 'Tmax of Donepezil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil Day -1', 'description': 'Participants received donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).'}, {'id': 'OG001', 'title': 'Donepezil Day 28', 'description': 'Participants received donepezil in combination with MK-1942 for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.00'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Tmax is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-1942 AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg once daily (QD), and MK-1942 twice daily (BID), for 28 days. Doses of MK-1942 were 8 mg (Week 1), 15 mg (Week 2), 30 mg (Week 3) and 50 mg (Week 4).'}, {'id': 'FG001', 'title': 'Placebo + Donepezil AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Male and female adult (≥50 to ≤85 years of age) participants with Alzheimer's disease (AD) and mild-to-moderate cognitive impairment were enrolled at 4 study centers in the United States."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-1942 AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg once daily (QD), and MK-1942 twice daily (BID), for 28 days. Doses of MK-1942 were 8 mg (Week 1), 15 mg (Week 2), 30 mg (Week 3) and 50 mg (Week 4).'}, {'id': 'BG001', 'title': 'Placebo + Donepezil AD', 'description': 'Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '69.4', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '69.2', 'spread': '5.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-16', 'size': 2839349, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-08T11:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2020-03-11', 'resultsFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-13', 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With ≥1 Adverse Event (AE)', 'timeFrame': 'Up to Day 42', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants Discontinuing From Study Therapy Due to an Adverse Event (AE)', 'timeFrame': 'Up to Day 28', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to Day 28', 'description': 'The number of participants with clinically significant 12-lead ECGs is presented. Recordings were made throughout the study, with the participant in a semi-recumbent position having rested in this position for at least 10 minutes beforehand.'}, {'measure': 'Number of Participants With Abnormal (Impaired) Results on Targeted Neurological Exams', 'timeFrame': 'Up to 29 days', 'description': 'The number of participants with abnormal (impaired) results on targeted neurological exams will be presented. The targeted neurological exam contains Modules 1, 2 and 5 of the general examination, focusing on arousal, cranial nerve function, and gait and will be administered several times throughout the treatment period starting on Day 1 up until Day 29. The number of participants with abnormal (impaired) results on targeted neurological exams will be reported. Each exam will be graded as Normal or Impaired with the abnormality described.'}, {'measure': 'Number of Participants Who Reported Suicidal Ideation and/or Behavior on Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to 42 days', 'description': "The number of participants with suicidality using the C-SSRS is presented. The C-SSR will be used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. C-SSRS assessment will be based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale. Suicidal ideation and/or behaviors identified on the C-SSRS may not be considered an adverse event, based on the investigator's judgment. Participants who report at least one occurrence of suicidal behavior or suicidal ideation will be counted as having experienced suicidality. Suicidal behavior includes suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation include a wish to die or active suicidal thought with or without method, intent or plan."}, {'measure': 'Change From Baseline in Heart Rate (HR)', 'timeFrame': 'Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdose', 'description': 'The mean change from baseline in HR is presented. Change in HR was determined the first day of treatment with a new dose of MK-1942. A negative value indicates a decrease in HR relative to baseline, and a positive value indicates an increase.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdose', 'description': 'The mean change from baseline in SBP is presented. Change in SBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in SBP relative to baseline, and positive values represent an increase.'}, {'measure': 'Mean Change From Baseline in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdose', 'description': 'The mean change from baseline in DBP is presented. Change in DBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in DBP relative to baseline, and positive values represent an increase.'}, {'measure': 'Number of Participants With Abnormal Clinical Chemistry Test Results Reported as Adverse Events', 'timeFrame': 'Up to 42 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal chemistry-related AEs is reported.'}, {'measure': 'Number of Participants With Abnormal Clinical Hematology Test Results Reported as Adverse Events', 'timeFrame': 'Up to 42 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal hematology-related AEs is reported.'}, {'measure': 'Number of Participants With Abnormal Urinalysis Results Reported as Adverse Events', 'timeFrame': 'Up to 42 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with an abnormal urinalysis results AE is reported.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to 12 Hours Postdose (AUC0-12) of MK-1942', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'AUC0-12 is reported for the first day of treatment of each MK-1942 dose.'}, {'measure': 'AUC From Dosing to 24 Hours Postdose (AUC0-24) of MK-1942', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'AUC0-24 is reported for the first day of treatment of each MK-1942 dose. Due to twice daily dosing, AUC0-24 was calculated as "AUC0-24 = AUC0-12 x 2".'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-1942', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Cmax is reported for the first day of treatment of each MK-1942 dose.'}, {'measure': 'Trough Plasma Concentration (Ctrough) of MK-1942', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Ctrough is reported for the first day of treatment of each MK-1942 dose. Data from healthy elderly participants used for statistical analyses are unpublished findings from study MK-1942-004.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of MK-1942', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Tmax is reported for the first day of treatment of each MK-1942 dose.'}, {'measure': 'Apparent Terminal Plasma Half-Life (t½) of MK-1942', 'timeFrame': 'Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 't½ is reported for MK-1942 50 mg.'}, {'measure': 'Apparent Clearance at Steady-state (CLss/F) of MK-1942', 'timeFrame': 'Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'CLss/F is reported for MK-1942 50 mg.'}, {'measure': 'Apparent Volume of Distribution at Steady State (Vzss/F) of MK-1942', 'timeFrame': 'Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Vzss/F is reported for MK-1942 50 mg.'}, {'measure': 'AUC0-24 of Donepezil', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'AUC0-24 is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28). Due to twice daily dosing, AUC0-24 was calculated as "AUC0-12 x 2".'}, {'measure': 'Cmax of Donepezil', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Cmax is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).'}, {'measure': 'Ctrough of Donepezil', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Ctrough is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).'}, {'measure': 'Tmax of Donepezil', 'timeFrame': 'Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdose', 'description': 'Tmax is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'Donepezil'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The study investigated the effects on safety and pharmacokinetics (PK) of MK-1942 and donepezil when co-administered to participants with Alzheimer's Disease with mild-to-moderate cognitive impairment stably treated with donepezil. The objectives of this study were to determine if the combination of MK-1942 with donepezil increases the incidence or severity of adverse events (AEs) previously reported for these agents alone, or results in unanticipated AEs in the patient population targeted for MK-1942 treatment. In addition, changes in the PK parameters of either MK-1942 or donepezil as a result of co-administration were assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) ≥18 and ≤35 kg/m\\^2, inclusive.\n* Is in good health based on medical history, physical examination, vital sign measures and electrocardiogram performed prior to randomization.\n* Have a negative urine drug screen prior to randomization.\n* Have a history of cognitive and functional decline with gradual onset and slow progression for at least one year before screening that is either corroborated or well-documented.\n* Be receiving donepezil (maximum dose: ≥10-mg, ≤15-mg) for symptomatic treatment of cognitive impairment associated with Alzheimer's dementia. The dose level must be stable for at least 1 month prior to screening.\n* Have a reliable and competent trial partner/caregiver who has a close relationship with the subject, has face-to-face contact at least three days a week for a minimum of six waking hours a week, and is willing to accompany the participant, if desired, to trial visits. The trial partner/caregiver should understand the nature of the trial and adhere to trial requirements (e.g., dosing, visit schedules, and nature and number of evaluations).\n* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Male participants must refrain from donating sperm PLUS agree to study guidelines regarding abstinent and/or contraception during the intervention period and for at least an additional 90 days (a spermatogenesis cycle) after the last dose of study intervention:\n* A female participant is eligible to participate if she is a women of nonchildbearing potential by study criteria.\n\nExclusion Criteria:\n\n* Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).\n* Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (CSSRS), or of harm to others in the opinion of the investigator.\n* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.\n* Has a history of uncontrolled, clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.\n* Candidates should not have a history of asthma, chronic obstructive pulmonary disease, urinary obstructions or gastrointestinal bleeding.\n* Has a history of cancer (malignancy) exceptions for (1) Adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or; (2) Other malignancies which have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study.\n* Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or non-prescription drugs or food.\n* Has evidence of a clinically relevant or unstable psychiatric disorder, based on The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, bipolar disorder, or delirium at the time of the pre-study (screening) visit, or has a history of clinically significant psychiatric disorder of the last 5 years.\n* Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the pre-study (screening) visit."}, 'identificationModule': {'nctId': 'NCT04308304', 'acronym': 'DDI', 'briefTitle': "MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Pharmacokinetics of MK-1942 Administered to Alzheimer's Disease Patients Receiving Donepezil Treatment.", 'orgStudyIdInfo': {'id': '1942-005'}, 'secondaryIdInfos': [{'id': 'MK-1942-005', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donepezil', 'description': 'Participants receive Dose Level 1: 8-mg MK-1942 twice daily (BID) x 7 days (7D), Day 1 to Day 7; Dose Level 2: 15-mg MK-1942 BID x 7D, Day 8 to Day 14; Dose Level 3: 30-mg MK-1942 BID x 7D, Day 15 to Day 21; Dose Level 4: ≤50-mg MK-1942 BID x 7D (Provisional Dose Level), Day 22 to Day 28 All participants to receive Donepezil once daily.', 'interventionNames': ['Drug: MK-1942', 'Drug: Donepezil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to MK-1942 BID x 21 \\[28\\] D All participants to receive Donepezil once daily.', 'interventionNames': ['Drug: Donepezil', 'Drug: Placebo']}], 'interventions': [{'name': 'MK-1942', 'type': 'DRUG', 'description': 'MK-1942 1 mg, 5 mg, and/or 10 mg capsules taken twice daily (BID) by mouth.', 'armGroupLabels': ['Donepezil']}, {'name': 'Donepezil', 'type': 'DRUG', 'description': 'Donepezil 5 mg and/or 10 mg tablets taken once daily (QD) by mouth.', 'armGroupLabels': ['Donepezil', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule matched to MK-1942 taken BID by mouth.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72758-6442', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland Research Northwest, LLC ( Site 0004)', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'Velocity Clinical Research, Hallandale Beach ( Site 0002)', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'iResearch Atlanta ( Site 0005)', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON ( Site 0003)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}