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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: Seltorexant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05307692

42847922ALZ2001 (Other Identifier)

CR109177

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Seltorexant

Experimental group

Description:

Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.

Treatment:

Drug: Seltorexant

Placebo

Placebo Comparator group

Description:

Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.

Treatment:

Drug: Placebo