A Study of Seltorexant in Participants With Probable Alzheimer's Disease

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05307692
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Seltorexant — DRUG
    Seltorexant 20 mg will be administered orally as a tablet.
  • Placebo — DRUG
    Matching placebo will be administered orally as a tablet.

Study Details

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.

Key Dates

Start date
May 19, 2022
Status verified
Apr 2025
Primary completion
Nov 10, 2023
Completion
Nov 10, 2023

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Seltorexant
    Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.
  • Placebo Comparator: Placebo
    Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.

Primary Outcome 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 [ Time Frame: Baseline (Day 1) and Day 43 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Medical Advancement Center of ArizonaTempeArizona85283-
Sunwise Clinical ResearchLafayetteCalifornia94549-
Luminous Clinical ResearchHomesteadFlorida33030-
Allied Biomedical Research Institute (ABRI), IncMiamiFlorida33155-4630-
Biovision MedicalMiamiFlorida33184-
Entrust Clinical ResearchMiamiFlorida33156-
Florida International Research Center (FIRC)MiamiFlorida33173-
Global Medical InstitutesMiamiFlorida33125-
IMIC IncMiamiFlorida33176-
Office of Emilio Mantero-Atienza, MDMiamiFlorida33135-
P&S Research, LLCMiamiFlorida33175-
Quantix ResearchMiamiFlorida33155-
South Florida Research Center Inc.Miami SpringsFlorida33166-
Intercoastal Medical GroupSarasotaFlorida34239-
Accel Clinical ResearchSeminoleFlorida33777-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
NeuroTrials Research IncAtlantaGeorgia30328-
Sonar Clinical ResearchAtlantaGeorgia30315-
Ochsner Medical CenterNew OrleansLouisiana70121-
Boston Clinical TrialsBostonMassachusetts02131-
Richmond Behavioral AssociatesStaten IslandNew York10312-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Gill NeuroscienceCypressTexas77429-
Wasatch Clinical ResearchSalt Lake CityUtah84107-
Memory Clinic IncBenningtonVermont05201-

Find similar trials in Tempe, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Medical Advancement Center of Arizona· Tempe, AZSunwise Clinical Research· Lafayette, CALuminous Clinical Research· Homestead, FLAllied Biomedical Research Institute (ABRI), Inc· Miami, FLBiovision Medical· Miami, FLEntrust Clinical Research· Miami, FL

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