Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06721156
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24", 'timeFrame': 'Baseline and up to approximately 24 weeks', 'description': 'The change from baseline in ADAS-Cog11 score at Week 24 is presented. ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The total possible score ranges from 0 to 70, with higher scores indicating greater cognitive impairment. Negative values indicate improvement relative to baseline, and vice versa.'}, {'measure': 'Number of Participants Who Experience One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 28 weeks', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Intervention Due to an AE', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.'}], 'secondaryOutcomes': [{'measure': "Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24", 'timeFrame': 'Baseline and up to approximately 24 weeks', 'description': "The overall score in ADCS-CGIC at Week 24 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study."}, {'measure': "Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 24", 'timeFrame': 'Baseline and up to approximately 24 weeks', 'description': "The change from baseline in ADCS-ADL score at Week 24 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23-item scale that includes 6 basic ADL items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity."}, {'measure': 'Change From Baseline in the ADAS-Cog11 Total Score at Week 12', 'timeFrame': 'Baseline and up to approximately 12 weeks', 'description': 'The change from baseline in ADAS-Cog11 score at Week 12 is presented. ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The total possible score ranges from 0 to 70, with higher scores indicating greater cognitive impairment. Negative values indicate improvement relative to baseline, and vice versa.'}, {'measure': 'ADCS-CGIC Overall Score at Week 12', 'timeFrame': 'Baseline and up to approximately 12 weeks', 'description': "The overall score in ADCS-CGIC at Week 12 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study."}, {'measure': 'Change From Baseline in the ADCS-ADL Total Score at Week 12', 'timeFrame': 'Baseline and up to approximately 12 weeks', 'description': "The change from baseline in ADCS-ADL score at Week 12 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23-item scale that includes 6 basic ADL items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Dementia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "Researchers want to learn if giving MK-1167 (the study medicine) along with acetylcholinesterase inhibitor (AChEI) therapy can improve symptoms of Alzheimer's disease dementia (AD dementia), such as memory and mental activity. AD dementia is the most common type of dementia. AChEI therapy is the standard treatment for AD dementia.\n\nThe goals of this study are to learn:\n\n* If at least one dose level (amount) of MK-1167 works to improve a person's memory and thinking compared to a placebo\n* About the safety of MK-1167 and if people tolerate it"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has mild to moderate Alzheimer's Disease (AD) dementia (ie, Stage 4 or Stage 5 AD) based on the Alzheimer's Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease\n* Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)\n* Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia\n* Has a designated study partner who can fulfill the requirements of this study. The study partner will need to spend sufficient time with the participant to be familiar with their overall function and behavior and be able to provide adequate information about the participant needed for the study including, knowledge of functional and basic activities of daily life, work/educational history, cognitive performance, emotional/psychological state, and general health status\n\nExclusion Criteria:\n\n* Has a known history of stroke or cerebrovascular disease\n* Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically\n* Has structural brain disease\n* Has a history of seizures or epilepsy\n* Has any other major CNS trauma, or infections that affect brain function (eg, Human immunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (COVID-19), including impact on cognition)\n* Has major medical illness or unstable medical condition\n* Has a history of malignancy\n* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)\n* Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases"}, 'identificationModule': {'nctId': 'NCT06721156', 'briefTitle': "A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy and Safety of MK-1167 as Adjunctive Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia", 'orgStudyIdInfo': {'id': '1167-008'}, 'secondaryIdInfos': [{'id': '2024-515539-31-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1309-3391', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': 'jRCT2031240682', 'type': 'REGISTRY', 'domain': 'jRCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-1167 3 mg', 'description': 'Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.', 'interventionNames': ['Drug: MK-1167']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1167 1 mg', 'description': 'Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.', 'interventionNames': ['Drug: MK-1167']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1167 0.3 mg', 'description': 'Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.', 'interventionNames': ['Drug: MK-1167']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants take placebo QD for up to approximately 24 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MK-1167', 'type': 'DRUG', 'description': 'MK-1167 oral capsule', 'armGroupLabels': ['MK-1167 0.3 mg', 'MK-1167 1 mg', 'MK-1167 3 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '602-839-6900'}], 'facility': "Banner Alzheimer's Institute ( Site 0110)", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92614', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-753-1663'}], 'facility': 'Irvine Clinical Research ( Site 0104)', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Anderson Clinical Research ( Site 0164)', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '818-990-2671'}], 'facility': 'California Neuroscience Research ( Site 0118)', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '561-968-2933'}], 'facility': 'JEM Research Institute / Headlands Research Network ( Site 0108)', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '561-374-8461'}], 'facility': 'Brain Matters Research-Neurology ( Site 0150)', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '561-374-8461'}], 'facility': 'Neuropsychiatric Research Center of Southwest Florida ( Site 0152)', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '305-825-6588'}], 'facility': 'Indago Research & Health Center, Inc ( Site 0128)', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32159', 'city': 'Lady Lake', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '352-500-5252'}], 'facility': 'K2 Medical Research THE VILLAGES ( Site 0166)', 'geoPoint': 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'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '407-705-3471'}], 'facility': 'Headlands Research Orlando ( Site 0169)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34997', 'city': 'Stuart', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '561-374-8461'}], 'facility': 'Brain Matters Research ( Site 0151)', 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '33634', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '813-800-5252'}], 'facility': 'K2 Medical Research ( Site 0165)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31909', 'city': 'Columbus', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Columbus Memory Center ( Site 0197)', 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( Site 0167)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '248-957-8940'}], 'facility': 'Quest Research Institute ( Site 0173)', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Velocity Clinical Research, Syracuse ( Site 0125)', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '12553', 'city': 'New Windsor', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '845-561-1270'}], 'facility': 'Mid Hudson Medical Research ( Site 0191)', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'zip': '28105', 'city': 'Matthews', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '704-610-4335'}], 'facility': 'Flourish Research - 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