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

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 (NPI-C) in participants with probable Alzheimer's Disease (AD) with clinically significant agitation/aggression.

Timeline

Start

2022-05-19

Primary completion

2023-11-10

Completion

2023-11-10

Outcome

Missed primary endpoint

registry analysis (superiority test); DB: Placebo vs DB: Seltorexant; p = 0.308; Difference of Least Square (LS) Means -1.5 (80% CI -3.41 to 0.39); Mixed model repeated measures NCT05307692 ↗

registry analysis (superiority test); DB: Placebo vs DB: Seltorexant; p = 0.282; Difference of Least Square (LS) Means -1.5 (80% CI -3.33 to 0.29); Mixed model repeated measures NCT05307692 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seltorexant	Small molecule	20 mg	Oral

Indications