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

March 27, 2024 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Medical Advancement Center of Arizona
    • California
      • Lafayette, California, United States, 94549
        • Sunwise Clinical Research
    • Florida
      • Homestead, Florida, United States, 33030
        • Luminous Clinical Research
      • Miami, Florida, United States, 33125
        • Global Medical Institutes
      • Miami, Florida, United States, 33175
        • P&S Research, LLC
      • Miami, Florida, United States, 33135
        • Office of Emilio Mantero-Atienza, MD
      • Miami, Florida, United States, 33156
        • Entrust Clinical Research
      • Miami, Florida, United States, 33176
        • IMIC, Inc.
      • Miami, Florida, United States, 33155
        • Quantix Research
      • Miami, Florida, United States, 33155-4630
        • Allied Biomedical Research Institute (ABRI), Inc
      • Miami, Florida, United States, 33173
        • Florida International Research Center (FIRC)
      • Miami, Florida, United States, 33184
        • Biovision Medical
      • Miami Springs, Florida, United States, 33166
        • South Florida Research Center Inc.
      • Sarasota, Florida, United States, 34239
        • Intercoastal Medical Group
      • Seminole, Florida, United States, 33777
        • Accel Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • NeuroTrials Research Inc
      • Atlanta, Georgia, United States, 30315
        • Sonar Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
    • New York
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Cypress, Texas, United States, 77429
        • Gill Neuroscience
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Memory Clinic Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant has received a diagnosis of probable Alzheimer Disease (AD) (Diagnostic and Statistical Manual of Mental Disorders-5 [DSM-5]) with the following characteristics at screening: Clinical Dementia Rating (CDR) global score greater than 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 on International Psychogeriatric Association (IPA) consensus clinical and research definition 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 screening and baseline with no more than 35 percent (%) of improvement in NPI-12 A/A domain score from the screening to baseline assessments
  • Female participants must be postmenopausal before study entry (amenorrhea for at least 12 months)
  • Body Mass Index (BMI) within the range 18-40 kilograms per square meter (kg/m^2) (inclusive)

Exclusion Criteria:

  • Participant fulfils diagnostic criteria for non-Alzheimer's Dementia: example, Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), and post-stroke dementia, based on clinical history. (Participants may be included with mixed AD/vascular dementia)
  • Participant has a clinically significant acute illness within 7 days prior to study intervention 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 as pain) or significant history of aggression prior to dementia based on investigator judgment
  • Participants who are not stable on concomitant medications or take prohibited medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seltorexant
Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.
Drug: Seltorexant
Seltorexant 20 mg will be administered orally as a tablet.
Other Names:
  • JNJ-42847922
Placebo Comparator: Placebo
Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.
Drug: Placebo
Matching placebo will be administered orally as a tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Neuropsychiatric Inventory-Clinician Rating (NPI-C) Agitation and Aggression (A plus A) Scores
Time Frame: Baseline up to Day 43
The NPI-12 is a measure of psychobehavioral disturbances assessing the frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain is rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being the product of the frequency and severity scores, such that each domain is scored from 1 to 12. The NPI-12 total score is the sum of the 12 domain scores, ranging from 0 (best) to 144 (worst). NPI-C is an instrument developed on the basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that can then be summed to a total score. Five domains will be measured in the study with NPI-C: Delusions, Hallucinations, Agitation, Aggression, Dysphoria, and will include both caregiver and participant interviews. Higher scores on the NPI-C are associated with a greater clinical severity of symptoms.
Baseline up to Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline on the Total Cohen-mansfield Agitation Inventory-Community Version (CMAI-C) Score
Time Frame: Baseline up to Day 43
The CMAI-C is a 37-item scale that measures the ability of a drug to reduce overall frequency of agitation symptoms, including aggressive behaviors. Individual items are rated on a scale of 1 (never) to 7 (several times per hour) in which a score of 7 represents the most frequent for each item assessed. The total score is a sum of all categories that ranges form 37-259, where higher score indicates greater severity.
Baseline up to Day 43
Change from Baseline in Sleep Disorder Inventory (SDI) Total Score
Time Frame: Baseline up to Day 43
SDI is based on a caregiver interview and an expanded version of one item of the NPI-12. It describes the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI total score ranges from 0-12 where higher score indicates greater severity.
Baseline up to Day 43
Plasma Concentrations of Seltorexant and its Metabolite
Time Frame: Day 15 and Day 43
Plasma samples will be analyzed to measure concentrations of seltorexant and its metabolite using a validated, specific, and sensitive Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC- MS/MS) method.
Day 15 and Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research and Development, LLC Clinical Trial, Janssen Research and Development LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109177
  • 42847922ALZ2001 (Other Identifier: Janssen Research and Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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