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

NCT05307692 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR10917742847922ALZ2001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 25

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (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

  The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was 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 product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was an instrument developed on basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.

  Baseline (Day 1) and Day 43

• Change From Baseline in NPI-C A+A at Day 43: Analyzed Under Estimand 2

  The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was 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 product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to 144 (worst), higher score represented greater frequency and worst severity of the symptoms. NPI-C was 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 were summed to a total score. NPI-C domains: agitation and aggression NPI-C A+A were scored based on both caregiver and participant interviews and score ranged from 0 (does not occur) to 63 (severe). Higher scores indicated more severity.

  Baseline (Day 1) and Day 43

Secondary Outcomes (3)

• Change From Baseline in Cohen-Mansfield Agitation Inventory- Community Version (CMAI-C) Total Score at Day 43

  Baseline (Day 1) and Day 43

• Change From Baseline in Sleep Disorder Inventory (SDI) Average Total Score at Day 43

  Baseline and Day 43

• Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)

  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)

Study Arms (2)

Seltorexant

EXPERIMENTAL

Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.

Drug: Seltorexant

Placebo

PLACEBO COMPARATOR

Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.

Drug: Placebo

Interventions

Seltorexant DRUG

Seltorexant 20 mg will be administered orally as a tablet.

Also known as: JNJ-42847922

Seltorexant

Placebo DRUG

Matching placebo will be administered orally as a tablet.

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (25)

Medical Advancement Center of Arizona

Tempe, Arizona, 85283, United States

Location

Sunwise Clinical Research

Lafayette, California, 94549, United States

Location

Luminous Clinical Research

Homestead, Florida, 33030, United States

Location

Global Medical Institutes

Miami, Florida, 33125, United States

Location

Office of Emilio Mantero-Atienza, MD

Miami, Florida, 33135, United States

Location

Allied Biomedical Research Institute (ABRI), Inc

Miami, Florida, 33155-4630, United States

Location

Quantix Research

Miami, Florida, 33155, United States

Location

Entrust Clinical Research

Miami, Florida, 33156, United States

Location

Florida International Research Center (FIRC)

Miami, Florida, 33173, United States

Location

P&S Research, LLC

Miami, Florida, 33175, United States

Location

IMIC Inc

Miami, Florida, 33176, United States

Location

Biovision Medical

Miami, Florida, 33184, United States

Location

South Florida Research Center Inc.

Miami Springs, Florida, 33166, United States

Location

Intercoastal Medical Group

Sarasota, Florida, 34239, United States

Location

Accel Clinical Research

Seminole, Florida, 33777, United States

Location

Sonar Clinical Research

Atlanta, Georgia, 30315, United States

Location

NeuroTrials Research Inc

Atlanta, Georgia, 30328, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Gill Neuroscience

Cypress, Texas, 77429, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Memory Clinic Inc

Bennington, Vermont, 05201, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

seltorexant

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research and Development, LLC Clinical Trial

  Janssen Research and Development LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 1, 2022
• Study Start: May 19, 2022
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: April 27, 2025
• Results First Posted: November 25, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (25)