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A Study of Seltorexant in Participants With Probable 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 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)

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 ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) 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 NPI-C A+A at Day 43: Analyzed Under Estimand 2
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
Secondary study objectives
Change From Baseline in Cohen-Mansfield Agitation Inventory- Community Version (CMAI-C) Total Score at Day 43
Change From Baseline in Sleep Disorder Inventory (SDI) Average Total Score at Day 43
Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)

Side effects data

From 2023 Phase 2 trial • 88 Patients • NCT05307692
3%
Malignant Biliary Obstruction
3%
Pancreatic Neuroendocrine Tumour
3%
Orchitis
3%
Neck Pain
3%
Tension Headache
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB: Placebo
FU: Seltorexant
DB: Seltorexant
Follow-up (FU): Placebo

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
~1700

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,403,081 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
~25 spots leftby Dec 2025
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