A 12-week, Multicenter, Active-treatment Extension Trial to check how safe, tolerable and effective Brexpiprazole is in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer’s Type
- Conditions
- Agitation Associated With Dementia of the Alzheimer's TypeTherapeutic area: Diseases [C] - Nervous System Diseases [C10]MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2018-002783-88-BG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 250
1.The investigator must assess the capacity of the subject to provide informed consent prior to enrollment. Once this determination is made by the investigator, the options for obtaining informed consent from or on behalf of the subject must be followed as provided in the protocol.
2.Subjects who completed 12 weeks of post-randomization treatment in Trial 331-14-213.
3.Institutionalized subjects with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject’s symptoms and has direct observation of the subject’s behavior. The identified caregiver can be a staff member of the institutionalized setting or another individual (eg, family member, family friend, hired professional caregiver) who meets the caregiver requirements.
Non-institutionalized subjects may not be living alone and must have an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject’s symptoms and has direct observation of the subject’s behavior.
4.Subjects who are able to satisfactorily comply with the protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 227
1.Subjects who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial.
2.Subjects with a substantial protocol violation during the course of their participation in the double-blind Trial 331-14-213. Lesser violations such as occasional visits outside of the acceptable window or a missing blood draw will not exclude a subject from participation in Trial 331-201-00182; however, continual lack of compliance with the visit schedule, trial assessments, or treatment regimen in the prior double-blind trial would be considered a substantial violation that would result in exclusion from Trial 331-201-00182. The medical monitor should be contacted if the investigator is unsure of a subject’s eligibility.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary outcome variable is the frequency and severity of adverse events (AEs; safety and tolerability of brexpiprazole).;Timepoint(s) of evaluation of this end point: The primary safety analysis is the frequency and severity of AEs ;Main Objective: To assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult subjects with Agitation in Alzheimer’s dementia (AAD).;Secondary Objective: Exploratory:To assess the long-term efficacy of oral brexpiprazole as treatment in adult subjects with Agitation in Alzheimer’s dementia.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: CMAI: Change from baseline CMAI total score at Week 6, Week 12, and last available visit<br>CGI-S: Change from baseline CGI-S score at Week 6, Week 12, and last available visit<br>;Secondary end point(s): Exploratory efficacy endpoints are as follows:<br>•Change from baseline CMAI total score at Week 6, Week 12, and last available visit<br>•Change from baseline Clinical Global Impression Severity of Illness (CGI-S) score, as related to agitation, at Week 6, Week 12, and last available visit<br>