Status:
COMPLETED
A Study of Seltorexant in Participants With Probable Alzheimer's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05307692
Start Date
May 19 2022
End Date
November 10 2023
Last Update
April 27 2025
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Advancement Center of Arizona
Tempe, Arizona, United States, 85283
2
Sunwise Clinical Research
Lafayette, California, United States, 94549
3
Luminous Clinical Research
Homestead, Florida, United States, 33030
4
Global Medical Institutes
Miami, Florida, United States, 33125