Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-05 @ 3:34 AM
Study NCT ID:
NCT05307692
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2022-03-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Seltorexant in Participants With Probable Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine']}, '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': 'C000655226', 'term': 'seltorexant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Study Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57', 'description': 'All-cause mortality was anlyzed on all randomized participants. Serious adverse events and other adverse events were analyzed on safety analysis set which included all randomized participants who took at least 1 dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'DB: Placebo', 'description': 'Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 44, 'otherNumAffected': 4, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 44, 'otherNumAffected': 6, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Follow-up (FU): Placebo', 'description': 'After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'FU: Seltorexant', 'description': 'After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Supraventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Malignant Biliary Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Tension Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Abnormal Dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Confusional Arousal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}], 'seriousEvents': [{'term': 'Pancreatic Neuroendocrine Tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Neuropsychiatric Inventory Clinician Version (NPI-C) Sum of Agitation and Aggression Domain Scores (NPI-C A+A) at Day 43: Analyzed Under Estimand 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Placebo', 'description': 'Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'OG001', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.6', 'spread': '8.35', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '9.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.308', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of Least Square (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.5', 'ciLowerLimit': '-3.41', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.47', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Day 43', 'description': 'The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set (FAS) included all randomized participants who took at least 1 dose of study intervention. 'N' (number of participants analyzed): participants evaluable for this outcome measure. Estimand 1 used to analyze benefit from seltorexant 20 mg versus placebo in adults and elderly participants with probable Alzheimer's disease (AD) with clinically significant agitation/aggression who took study intervention as directed and regardless treatment discontinuation without treatment switch."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in NPI-C A+A at Day 43: Analyzed Under Estimand 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Placebo', 'description': 'Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'OG001', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.6', 'spread': '8.25', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '9.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.282', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of Least Square (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.5', 'ciLowerLimit': '-3.33', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.42', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Day 43', 'description': 'The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on the basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set (FAS) included all randomized participants who took at least 1 dose of study intervention. 'N' (number of participants analyzed): participants evaluable for this outcome measure. Estimand 2 was used to analyze benefit from seltorexant 20 mg versus placebo in adults and elderly participants with probable AD with clinically significant agitation/aggression who took study intervention as directed and regardless of treatment discontinuation without treatment switch."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cohen-Mansfield Agitation Inventory- Community Version (CMAI-C) Total Score at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Placebo', 'description': 'Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'OG001', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.5', 'spread': '18.67', 'groupId': 'OG000'}, {'value': '-20.3', 'spread': '21.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Day 43', 'description': 'The CMAI-C, 37-item scale, measured the ability of a drug to reduce overall frequency of agitation symptoms, including aggressive behaviors. Individual items were rated by the clinician on a scale of 1 (never) to 7 (several times per hour) in which higher score represented the most frequent for each item assessed. CMAI-C total score was a sum of all categories that ranged from 37 (never) to 259 (several times), where higher score indicated greater severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who took at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Disorder Inventory (SDI) Average Total Score at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Placebo', 'description': 'Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'OG001', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 43', 'description': 'SDI: based on caregiver (CG) interview and expanded version of item 11 (night-time behavioral disturbances) of NPI-12. It described frequency, severity and CG burden of sleep-disturbed behaviors for period prior to its administration. It consisted of 7 sub-questions from NPI-12 sleep disturbance item. Each sub-question was made into separate questions with frequency, severity, and CG distress rated with respect to participant. SDI score derived after CG rated frequency, severity of each of 7 separate sleep disturbance symptoms. CG distress ratings were not part of SDI total score, but distress was measured. Frequency scored on scale of 0 (not present) to 4 (once or more per day), severity scored on scale of 0 (not present) to 3 (occurrence of nighttime behaviors) and CG distress rated on scale of 0 (not at all) to 5 (extremely). SDI average total score=average frequency of item 1 to 7 multiplied with average severity of items 1 to 7; ranged from 0 to 12; higher score=greater severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who took at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.'}], 'classes': [{'title': 'Total Seltorexant', 'categories': [{'measurements': [{'value': '121', 'spread': '156', 'groupId': 'OG000'}]}]}, {'title': 'Total M12', 'categories': [{'measurements': [{'value': '141', 'spread': '164', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Either Day 15 (8 and 14 hours post dose on night of Day 14) or Day 43 (8 and 14 hours post dose on night of Day 42)', 'description': 'The pharmacokinetic (PK) sample collection was done based on the availability of the participants either on Day 15 or 43 and thus collected data were analyzed and summary data were reported in this outcome measure. Plasma samples were analyzed using liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS) method.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all randomized participants to the seltorexant treatment group and with at least one PK sample taken. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB: Placebo', 'description': 'Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'FG001', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'FG002', 'title': 'Follow-up (FU): Placebo', 'description': 'After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.'}, {'id': 'FG003', 'title': 'FU: Seltorexant', 'description': 'After the completion of double-blind phase, participants entered the post-treatment follow up phase and were followed up until Day 57.'}], 'periods': [{'title': 'Double-blind (DB) Phase (Day 1- Day 43):', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol-specified withdrawal criterion met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'FU Phase (Day 43 to Day 57):', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'comment': 'Three participants, who discontinued treatment during the DB phase (and so did not complete DB). They continued and entered the follow up phase.', 'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DB: Placebo', 'description': 'Participants received placebo matching to seltorexant tablet orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'BG001', 'title': 'DB: Seltorexant', 'description': 'Participants received seltorexant 20 milligrams (mg) orally once daily at bedtime from Day 1 to Day 42.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.6', 'spread': '7.75', 'groupId': 'BG000'}, {'value': '73.4', 'spread': '6.18', 'groupId': 'BG001'}, {'value': '73', 'spread': '6.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Adults (18-64 years)', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'From 65 to 84 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': '85 years and over', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Categorical', 'classes': [{'title': 'Adults (18-64 years)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'From 65 to 84 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': '85 years and over', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all randomized participants who took at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-08', 'size': 2607022, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-29T06:52', 'hasProtocol': True}, {'date': '2023-11-16', 'size': 1263299, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-29T06:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2022-03-25', 'resultsFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-29', 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Neuropsychiatric Inventory Clinician Version (NPI-C) Sum of Agitation and Aggression Domain Scores (NPI-C A+A) at Day 43: Analyzed Under Estimand 1', 'timeFrame': 'Baseline (Day 1) and Day 43', 'description': 'The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.'}, {'measure': 'Change From Baseline in NPI-C A+A at Day 43: Analyzed Under Estimand 2', 'timeFrame': 'Baseline (Day 1) and Day 43', 'description': 'The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on the basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Cohen-Mansfield Agitation Inventory- Community Version (CMAI-C) Total Score at Day 43', 'timeFrame': 'Baseline (Day 1) and Day 43', 'description': 'The CMAI-C, 37-item scale, measured the ability of a drug to reduce overall frequency of agitation symptoms, including aggressive behaviors. Individual items were rated by the clinician on a scale of 1 (never) to 7 (several times per hour) in which higher score represented the most frequent for each item assessed. CMAI-C total score was a sum of all categories that ranged from 37 (never) to 259 (several times), where higher score indicated greater severity.'}, {'measure': 'Change From Baseline in Sleep Disorder Inventory (SDI) Average Total Score at Day 43', 'timeFrame': 'Baseline and Day 43', 'description': 'SDI: based on caregiver (CG) interview and expanded version of item 11 (night-time behavioral disturbances) of NPI-12. It described frequency, severity and CG burden of sleep-disturbed behaviors for period prior to its administration. It consisted of 7 sub-questions from NPI-12 sleep disturbance item. Each sub-question was made into separate questions with frequency, severity, and CG distress rated with respect to participant. SDI score derived after CG rated frequency, severity of each of 7 separate sleep disturbance symptoms. CG distress ratings were not part of SDI total score, but distress was measured. Frequency scored on scale of 0 (not present) to 4 (once or more per day), severity scored on scale of 0 (not present) to 3 (occurrence of nighttime behaviors) and CG distress rated on scale of 0 (not at all) to 5 (extremely). SDI average total score=average frequency of item 1 to 7 multiplied with average severity of items 1 to 7; ranged from 0 to 12; higher score=greater severity.'}, {'measure': 'Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)', 'timeFrame': 'Either Day 15 (8 and 14 hours post dose on night of Day 14) or Day 43 (8 and 14 hours post dose on night of Day 42)', 'description': 'The pharmacokinetic (PK) sample collection was done based on the availability of the participants either on Day 15 or 43 and thus collected data were analyzed and summary data were reported in this outcome measure. Plasma samples were analyzed using liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS) method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of Agitation and Aggression domain scores (A plus A) of the Neuropsychiatric Inventory-Clinician rating (NPI-C) in participants with probable Alzheimer's Disease (AD) with clinically significant agitation/aggression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has received a diagnosis of probable Alzheimer Disease (AD) (Diagnostic and Statistical Manual of Mental Disorders-5 \\[DSM-5\\]) with the following characteristics at screening: Clinical Dementia Rating (CDR) global score greater than or equal to (\\>=) 1; Mini-Mental State Examination (MMSE) total score of 10 to 24 (inclusive)\n* Participant meets the criteria of a syndrome diagnosis of agitation based on International Psychogeriatric Association (IPA) consensus clinical and research definition of agitation in cognitive disorders for at least 2 weeks before screening\n* Participant meets the criteria of Neuropsychiatric Inventory (NPI-12) Agitation/Aggression (A/A) domain score \\>= 4 with frequency score \\>= 2 at screening and baseline with no more than 35 percent (%) of improvement in NPI-12 A/A domain score from the screening to baseline assessments\n* Female participants must be postmenopausal before study entry (amenorrhea for at least 12 months)\n* Body Mass Index (BMI) within the range 18-40 kilograms per square meter (kg/m\\^2) (inclusive)\n\nExclusion Criteria:\n\n* Participant fulfils diagnostic criteria for non-Alzheimer's Dementia: example, Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), and post-stroke dementia, based on clinical history. (Participants may be included with mixed AD/vascular dementia)\n* Participant has a clinically significant acute illness within 7 days prior to study intervention administration\n* Participants with a history of delirium within 30 days prior to or during screening\n* Participant with a cause of agitation that is not secondary to dementia (such as pain) or significant history of aggression prior to dementia based on investigator judgment\n* Participants who are not stable on concomitant medications or take prohibited medications"}, 'identificationModule': {'nctId': 'NCT05307692', 'briefTitle': "A Study of Seltorexant in Participants With Probable Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': "A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, and Clinical Efficacy of Seltorexant (JNJ-42847922) on Behavioral and Psychological Symptoms of Dementia in Patients With Probable Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'CR109177'}, 'secondaryIdInfos': [{'id': '42847922ALZ2001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seltorexant', 'description': 'Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.', 'interventionNames': ['Drug: Seltorexant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Seltorexant', 'type': 'DRUG', 'otherNames': ['JNJ-42847922'], 'description': 'Seltorexant 20 mg will be administered orally as a tablet.', 'armGroupLabels': ['Seltorexant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo will be administered orally as a tablet.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Advancement Center of Arizona', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '94549', 'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'Sunwise Clinical Research', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'zip': '33030', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Luminous Clinical Research', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Global Medical Institutes', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Office of Emilio Mantero-Atienza, MD', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155-4630', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Allied Biomedical Research Institute (ABRI), Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Quantix Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Entrust Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida International Research Center (FIRC)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'P&S Research, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'IMIC Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33184', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Biovision Medical', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33166', 'city': 'Miami Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Research Center Inc.', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Intercoastal Medical Group', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33777', 'city': 'Seminole', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Clinical Research', 'geoPoint': {'lat': 27.83975, 'lon': -82.79121}}, {'zip': '30315', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sonar Clinical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research Inc', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Clinical Trials', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Richmond Behavioral Associates', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77429', 'city': 'Cypress', 'state': 'Texas', 'country': 'United States', 'facility': 'Gill Neuroscience', 'geoPoint': {'lat': 29.96911, 'lon': -95.69717}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Wasatch Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05201', 'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Memory Clinic Inc', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}], 'overallOfficials': [{'name': 'Janssen Research and Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research and Development LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}