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

Last updated: March 29, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Seltorexant

Placebo

Clinical Study ID

NCT05307692
CR109177
42847922ALZ2001
  • Ages 55-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has received a diagnosis of probable Alzheimer Disease (AD) (Diagnosticand Statistical Manual of Mental Disorders-5 [DSM-5]) with the followingcharacteristics at screening: Clinical Dementia Rating (CDR) global score greaterthan or equal to (>=) 1; Mini-Mental State Examination (MMSE) total score of 10 to 24 (inclusive)

  • Participant meets the criteria of a syndrome diagnosis of agitation based onInternational Psychogeriatric Association (IPA) consensus clinical and researchdefinition of agitation in cognitive disorders for at least 2 weeks before screening

  • Participant meets the criteria of Neuropsychiatric Inventory (NPI-12)Agitation/Aggression (A/A) domain score >= 4 with frequency score >= 2 at screeningand baseline with no more than 35 percent (%) of improvement in NPI-12 A/A domainscore from the screening to baseline assessments

  • Female participants must be postmenopausal before study entry (amenorrhea for atleast 12 months)

  • Body Mass Index (BMI) within the range 18-40 kilograms per square meter (kg/m^2) (inclusive)

Exclusion

Exclusion Criteria:

  • Participant fulfils diagnostic criteria for non-Alzheimer's Dementia: example,Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), and post-strokedementia, based on clinical history. (Participants may be included with mixedAD/vascular dementia)

  • Participant has a clinically significant acute illness within 7 days prior to studyintervention administration

  • Participants with a history of delirium within 30 days prior to or during screening

  • Participant with a cause of agitation that is not secondary to dementia (such aspain) or significant history of aggression prior to dementia based on investigatorjudgment

  • Participants who are not stable on concomitant medications or take prohibitedmedications

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Seltorexant
Phase: 2
Study Start date:
May 19, 2022
Estimated Completion Date:
November 10, 2023

Connect with a study center

  • Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)

    Kyiv, 02192
    Ukraine

    Site Not Available

  • Onyx Clinical Research

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Medical Advancement Center of Arizona

    Phoenix, Arizona 85051
    United States

    Site Not Available

  • Medical Advancement Center of Arizona

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Advanced Research Center Inc

    Anaheim, California 92805
    United States

    Site Not Available

  • Sunwise Clinical Research

    Lafayette, California 94549
    United States

    Site Not Available

  • Luminous Clinical Research

    Homestead, Florida 33030
    United States

    Site Not Available

  • Allied Biomedical Research Institute (ABRI), Inc

    Miami, Florida 33155-4630
    United States

    Site Not Available

  • Biovision Medical

    Miami, Florida 33184
    United States

    Site Not Available

  • Entrust Clinical Research

    Miami, Florida 33156
    United States

    Site Not Available

  • Florida International Research Center (FIRC)

    Miami, Florida 33173
    United States

    Site Not Available

  • Global Medical Institutes

    Miami, Florida 33125
    United States

    Site Not Available

  • IMIC Inc

    Miami, Florida 33176
    United States

    Site Not Available

  • IMIC, Inc.

    Miami, Florida 33176
    United States

    Site Not Available

  • Office of Emilio Mantero-Atienza, MD

    Miami, Florida 33135
    United States

    Site Not Available

  • P&S Research, LLC

    Miami, Florida 33175
    United States

    Site Not Available

  • Quantix Research

    Miami, Florida 33155
    United States

    Site Not Available

  • South Florida Research Center Inc.

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • IMIC, Inc.

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Accel Clinical Research

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Intercoastal Medical Group

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Accel Clinical Research

    Seminole, Florida 33777
    United States

    Site Not Available

  • Meridien Research

    Tampa, Florida 33634
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • NeuroTrials Research Inc

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Sonar Clinical Research

    Atlanta, Georgia 30315
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Onyx Clinical Research

    Flint, Michigan 48532
    United States

    Site Not Available

  • Mid Hudson Medical Research

    New Windsor, New York 12572
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Gill Neuroscience

    Cypress, Texas 77429
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Memory Clinic Inc

    Bennington, Vermont 05201
    United States

    Site Not Available

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