CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
Seltorexant +1 moredrug
Likely dose
Seltorexant 20 mg orally once dailyAI-extracted
Key inclusion· 5
  • ✓Probable Alzheimer Disease diagnosis (DSM-5) with CDR global score ≥1 and MMSE total score 10-24
  • ✓Meets IPA consensus clinical and research definition of agitation syndrome for at least 2 weeks before screening
  • ✓NPI-12 Agitation/Aggression domain score ≥4 with frequency score ≥2 at screening and baseline, with ≤35% improvement from screening to baseline
  • ✓Postmenopausal females (amenorrhea ≥12 months)
Key exclusion· 5
  • ✕Non-Alzheimer's dementia diagnoses including Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), post-stroke dementia (mixed AD/vascular dementia allowed)
  • ✕Clinically significant acute illness within 7 days prior to study drug administration
  • ✕History of delirium within 30 days prior to or during screening
  • ✕Agitation caused by factors other than dementia (e.g., pain) or significant history of aggression prior to dementia onset

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05307692
NCT05307692Phase 2Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Apr 1, 2022·Updated Apr 27, 2025

In Brief

A Phase 2 clinical trial evaluating Seltorexant and Placebo for Alzheimer Disease. Completed, enrolled 88 participants across 25 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedApr 1, 2022
Enrollment StartMay 19, 2022
Primary CompletionNov 10, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.3 years ago

Interventions

Seltorexantdrug

Seltorexant 20 mg will be administered orally as a tablet.

Placebodrug

Matching placebo will be administered orally as a tablet.