CompletedPhase 2Results posted

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

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

Lead sponsor

Janssen Research & Development, LLC

Asset

Seltorexant

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global ≥1•MMSE 10-24

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID42847922ALZ2001Janssen Research & Development, LLC

Org study IDCR109177

NCT IDNCT05307692

Timeline

Milestones

Study first posted2022-04-01actual

Study start2022-05-19actual

Primary completion2023-11-10actual

Study completion2023-11-10actual

Results first posted2024-11-25actual

Last update posted2025-04-27actual

Assets

Drug assets

Seltorexant

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Behavior / neuropsychiatric

8 endpoints

Primary/protocol endpoint

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

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/protocol endpoint

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

Time frame:Baseline (Day 1) and Day 43

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

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

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
DB: Placebon=37 Participants	-9.6	8.35
DB: Seltorexantn=36 Participants	-13.4	9.31

Difference of Least Square (LS) Means-1.580% CI-3.41 - 0.39p0.308Mixed model repeated measures

Primary/registry result

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

Time frame:Baseline (Day 1) and Day 43

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
DB: Placebon=38 Participants	-9.6	8.25
DB: Seltorexantn=36 Participants	-13.4	9.31

Difference of Least Square (LS) Means-1.580% CI-3.33 - 0.29p0.282Mixed model repeated measures

Secondary/protocol endpoint

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

Time frame:Baseline (Day 1) and Day 43

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Day 43

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline (Day 1) and Day 43

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
DB: Placebon=38 Participants	-17.5	18.67
DB: Seltorexantn=36 Participants	-20.3	21.69

Secondary/registry result

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

Time frame:Baseline and Day 43

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
DB: Placebon=36 Participants	-0.8	1.02
DB: Seltorexantn=36 Participants	-0.5	0.90

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)

Time frame: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)

concentration, descriptive

Secondary/registry result

Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)

Time frame: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)

concentration, descriptive

Posted result

Group	Value (mean), nanograms per milliliter (ng/mL)	Standard deviation
DB: SeltorexantTotal Seltorexantn=22 Participants	121	156
Total M12n=22 Participants	141	164

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.