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Alzheimer DiseasePhase 2NCT05307692

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

A Phase 2 study testing Seltorexant in people with Alzheimer Disease, run by Janssen Research & Development, LLC at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Seltorexant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
25 sitesUnited States
Study dates
19 May 2022to 10 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Sonar Clinical Research

    Atlanta, Georgia, 30315

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Memory Clinic Inc

    Bennington, Vermont, 05201

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Gill Neuroscience

    Cypress, Texas, 77429

  • Luminous Clinical Research

    Homestead, Florida, 33030

  • Sunwise Clinical Research

    Lafayette, California, 94549

  • Global Medical Institutes

    Miami, Florida, 33125

  • Office of Emilio Mantero-Atienza, MD

    Miami, Florida, 33135

  • Allied Biomedical Research Institute (ABRI), Inc

    Miami, Florida, 33155-4630

  • Quantix Research

    Miami, Florida, 33155

  • Entrust Clinical Research

    Miami, Florida, 33156

  • Florida International Research Center (FIRC)

    Miami, Florida, 33173

  • P&S Research, LLC

    Miami, Florida, 33175

  • IMIC Inc

    Miami, Florida, 33176

  • Biovision Medical

    Miami, Florida, 33184

  • South Florida Research Center Inc.

    Miami Springs, Florida, 33166

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • Accel Clinical Research

    Seminole, Florida, 33777

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Medical Advancement Center of Arizona

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: 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.

Being tested
Seltorexant, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SeltorexantDrug

    Also called JNJ-42847922

    Seltorexant 20 mg will be administered orally as a tablet.

  • PlaceboDrug

    Matching placebo will be administered orally as a tablet.

Study groups in NCT05307692
Study groupRoleWhat they receive
SeltorexantExperimentalParticipants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.
Receives: Drug: Seltorexant
PlaceboPlacebo comparatorParticipants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Day 1) and Day 43

  2. 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.

    Measured: Baseline (Day 1) and Day 43

Secondary outcomes (3)

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

    The CMAI-C, 37-item scale, measured the ability of a drug to reduce overall frequency of agitation symptoms, including aggressive behaviors. Individual items were rated by the clinician on a scale of 1 (never) to 7 (several times per hour) in which higher score represented the most frequent for each item assessed. CMAI-C total score was a sum of all categories that ranged from 37 (never) to 259 (several times), where higher score indicated greater severity.

    Measured: Baseline (Day 1) and Day 43

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

    SDI: based on caregiver (CG) interview and expanded version of item 11 (night-time behavioral disturbances) of NPI-12. It described frequency, severity and CG burden of sleep-disturbed behaviors for period prior to its administration. It consisted of 7 sub-questions from NPI-12 sleep disturbance item. Each sub-question was made into separate questions with frequency, severity, and CG distress rated with respect to participant. SDI score derived after CG rated frequency, severity of each of 7 separate sleep disturbance symptoms. CG distress ratings were not part of SDI total score, but distress was measured. Frequency scored on scale of 0 (not present) to 4 (once or more per day), severity scored on scale of 0 (not present) to 3 (occurrence of nighttime behaviors) and CG distress rated on scale of 0 (not at all) to 5 (extremely). SDI average total score=average frequency of item 1 to 7 multiplied with average severity of items 1 to 7; ranged from 0 to 12; higher score=greater severity.

    Measured: Baseline and Day 43

  3. Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)

    The pharmacokinetic (PK) sample collection was done based on the availability of the participants either on Day 15 or 43 and thus collected data were analyzed and summary data were reported in this outcome measure. Plasma samples were analyzed using liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS) method.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start19 May 2022
  3. Primary completion10 Nov 2023
  4. Study completion10 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05307692
Sponsor's protocol ID
CR109177
Other IDs
42847922ALZ2001
Status last verified
Apr 2025
First submitted
25 Mar 2022
Last updated
27 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Seltorexant in people with Alzheimer Disease, run by Janssen Research & Development, LLC at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05307692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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