Clinical Research to to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole compared with placebo.
The trial consists of a 12-week double-blind treatment period with a 30 day follow-up.
The trial population will include male and female subjects between 55 and 90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either in an institutionalized setting or in a non-institutionalized setting where the subject is not living alone.
This trial will analyze data gathered from 225 subjects at multiple countries.
Subjects may also be eligible to enter an active extension trial, following completion of this trial.
Source: ClinicalTrials.gov : https://clinicaltrials.gov/ct2/show/record/NCT03548584?recrs=ab&cond=Alzheimer+Agitation&cntry=US&draw=2&rank=2
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