Study on subjects affected by agitation associated with Alzheimer's.
Research type
Research Study
Full title
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer’s Type
IRAS ID
152454
Contact name
Louris Elias
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2013-000503-17
Clinicaltrials.gov Identifier
Research summary
This is a global phase 3, 12 week, multi-centre, randomized, double-blind, placebo-controlled study. It is designed to assess the efficacy, safety and tolerability of brexpiprazole (dose range of 0.5mg to 2mg/day) in the treatment of agitation in patients with Alzheimer’s disease (AD).
Brexpiprazole is an organic compound synthesized by Otsuka Pharmaceutical Co, Ltd. Patients with AD between 55-90 years of age will be recruited from care homes or the potential subjects may beliving at home with a caregiver. It is expected around 330 participants be screened for 230 to be enrolled into the study. Enrolment period will be around 3.5 years.
With informed consent, patients will go through 3 periods: the screening period ranging between 2 to 42 days to determine the patient’s eligibility and washout prohibited concomitant pharmacotherapy. The second period is the treatment period for 12 weeks, where patients will be randomly assigned to either brexpiprazole or the placebo arm. Patients will get a minimal of 8 visits from the research team during the treatment period. The 3rd period is a follow-up at 30 (+2) days after the last dose for a safety evaluation. Individual participation for subjects who complete the trial will range from 16 to 22 weeks.
The efficacy of brexpiprazole will be assessed by clinical observations using appropriate tools and interviews with the caregiver. Participants will be asked to wear a portable device like a wristwatch to record movement levels. Physical examination, blood & urine samples, ECG will be done at some points to check eligibility and health status during the study. The study doctor will obtain a head CT / MRI scan if one was not done previously. Pharmacogenomics blood testing will be optional for those who consent to it, which will allow researchers to understand if genes play a part in agitation in AD.
REC name
East of England - Essex Research Ethics Committee
REC reference
14/EE/1163
Date of REC Opinion
29 Jan 2015
REC opinion
Further Information Favourable Opinion