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Seltorexant for Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15 and day 43

Summary

This trial is testing seltorexant, a medication that may help reduce agitation and aggression in people with Alzheimer's Disease. The study focuses on those who have significant symptoms that are hard to manage. Seltorexant works by calming brain activity, which might help improve mood and behavior.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15 and day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 and day 43 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Neuropsychiatric Inventory-Clinician Rating (NPI-C) Agitation and Aggression (A plus A) Scores
Secondary study objectives
Change From Baseline on the Total Cohen-mansfield Agitation Inventory-Community Version (CMAI-C) Score
Change from Baseline in Sleep Disorder Inventory (SDI) Total Score
Plasma Concentrations of Seltorexant and its Metabolite

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SeltorexantExperimental Treatment1 Intervention
Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seltorexant
2021
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,004 Previous Clinical Trials
6,402,737 Total Patients Enrolled
Janssen Research and Development, LLC Clinical TrialStudy DirectorJanssen Research and Development LLC
9 Previous Clinical Trials
447,994 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05307692 — Phase 2
Alzheimer's Disease Research Study Groups: Placebo, Seltorexant
Alzheimer's Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05307692 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307692 — Phase 2
~20 spots leftby Nov 2025
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