A Study of Seltorexant in Participants With Probable Alzheimer's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT05307692
- Run by
- Janssen Research & Development, LLC
- People needed
- 88
- Starts
- 2022-05-19
- Expected to finish
- 2023-11-10
- Last updated by the study team
- 2025-04-27
Who can join
Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Medical Advancement Center of Arizona — Tempe, Arizona, United States
- Sunwise Clinical Research — Lafayette, California, United States
- Luminous Clinical Research — Homestead, Florida, United States
- Global Medical Institutes — Miami, Florida, United States
- Office of Emilio Mantero-Atienza, MD — Miami, Florida, United States
- Allied Biomedical Research Institute (ABRI), Inc — Miami, Florida, United States
- Quantix Research — Miami, Florida, United States
- Entrust Clinical Research — Miami, Florida, United States
- Florida International Research Center (FIRC) — Miami, Florida, United States
- P&S Research, LLC — Miami, Florida, United States
- IMIC Inc — Miami, Florida, United States
- Biovision Medical — Miami, Florida, United States
- South Florida Research Center Inc. — Miami Springs, Florida, United States
- Intercoastal Medical Group — Sarasota, Florida, United States
- Accel Clinical Research — Seminole, Florida, United States
- Sonar Clinical Research — Atlanta, Georgia, United States
- NeuroTrials Research Inc — Atlanta, Georgia, United States
- Atlanta Center for Medical Research — Atlanta, Georgia, United States
- Ochsner Medical Center — New Orleans, Louisiana, United States
- Boston Clinical Trials — Boston, Massachusetts, United States
- Richmond Behavioral Associates — Staten Island, New York, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Gill Neuroscience — Cypress, Texas, United States
- Wasatch Clinical Research — Salt Lake City, Utah, United States
- Memory Clinic Inc — Bennington, Vermont, United States
Full record on ClinicalTrials.gov
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