Trials / Completed
CompletedNCT05307692
A Study of Seltorexant in Participants With Probable Alzheimer's Disease
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Seltorexant | Seltorexant 20 mg will be administered orally as a tablet. |
| DRUG | Placebo | Matching placebo will be administered orally as a tablet. |
Timeline
- Start date
- 2022-05-19
- Primary completion
- 2023-11-10
- Completion
- 2023-11-10
- First posted
- 2022-04-01
- Last updated
- 2025-04-27
- Results posted
- 2024-11-25
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05307692. Inclusion in this directory is not an endorsement.