Rollover study of OPC 34712 in subjects with Alzheimer
Research type
Research Study
Full title
A 2-month, Observational, Rollover Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer’s Type who were Previously Treated with Brexpiprazole (OPC-34712) or Placebo in a Phase 3, Double-blind Trial
IRAS ID
179025
Contact name
Louris Elias
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2014-000424-23
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EudraCT No, 2014-000424-23; IND No, 115,960
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
This is an observational study to evaluate the safety of participants who already participated the previous dementia study and treated with brexpiprazole or placebo during a phase 3 brexpiprazole trial of subjects with agitation associated with dementia of the Alzheimer’s type.
This is an observational study, which means that the participant will not be taking any study medication. The study doctor will treat their agitation associated with Alzheimer’s disease as he/she thinks is best for them.
When participants completed all visits of the double-blind treatment period and the 30 day safety follow-up visit in a previous study, they will be asked to participate in this observational study. If the participants terminated early from the previous phase 3 brexpiprazole study will not be eligible to roll over into this trial.
There will be 3 visits: at baseline, Month 1 (5 days), and Month 2 (5 days)/Early Termination (ET). Visits can be placed at a hospital, at the residential facility, or can be conducted as a telephone contact.
The 30-day safety follow up visit of the previous study is the baseline visit (Day 0) of this study. Participants will sign a separate informed consent form for participation in this study before any procedures specific to the observational trial are performed.
Participants must have a caregiver who can spend a minimum of 2 hours per day for 4 days per week with them in order to assess changes in the subject’s condition. At the time of the subject’s baseline visit, the caregiver should acknowledge and agree to undertake all the tasks designated for this study.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0259
Date of REC Opinion
20 Aug 2015
REC opinion
Further Information Favourable Opinion