NCT05307692CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 25 Mar 2022
- Start date
- 19 May 2022
- Primary completion date
- 10 Nov 2023
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Alzheimer disease
- NCT number
- NCT05307692
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 88
- From 19 May 2022 to the primary completion date, 10 Nov 2023
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Who the study is looking for
- 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)
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sonar Clinical Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Atlanta Center for Medical Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| NeuroTrials Research Inc Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Memory Clinic, Inc. Coordinator of this site? Confirm its status | Bennington | United States | Unknown status |
| Boston Clinical Trials Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Gill Neuroscience Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| Luminous Clinical Research Coordinator of this site? Confirm its status | Homestead | United States | Unknown status |
| Sunwise Clinical Research Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Allied Biomedical Research Institute (ABRI), Inc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Florida International Research Center (FIRC) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Office of Emilio Mantero-Atienza, MD Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Global Medical Institutes Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Entrust Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Quantix Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| IMIC, Inc. Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Biovision Medical Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| P&S Research, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| South Florida Research Center Inc. Coordinator of this site? Confirm its status | Miami Springs | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Ochsner Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Wasatch Clinical Research Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Intercoastal Medical Group Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Accel Clinical Research Coordinator of this site? Confirm its status | Seminole | United States | Unknown status |
| Richmond Behavioral Associates Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Medical Advancement Center of Arizona Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.