Agitation Associated with Dementia of the Alzheimer's Type
Conditions
Interventions
Product Name: Brexpiprazole
Product Code: OPC-34712
Pharmaceutical Form: Tablet
INN or Proposed INN: Brexpiprazole
CAS Number: 913611-97-9
Current Sponsor code: OPC-34712
Other descriptive name: BREXP
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -The investigator must assess the capacity of the subject to provide informed consent prior to enrollment and throughout the course of the trial. Once this determination is made by the investigator, the options for obtaining informed consent from and/or on behalf of the subject must be followed accordingly: - If the subject is deemed capable by the investigator, written informed consent will be obtained from the subject prior to the initiation of any trial protocol-required procedures. In such cases, acknowledgement from the subject?s legally acceptable representative (an individual, or judicial or other body, authorized under applicable law to consent to the subject?s participation in the clinical trial on behalf of that prospective subject) will also be obtained in accordance with state and/or local regulations prior to initiation of any trial protocol-required procedures. - If the subject was initially deemed capable of providing informed consent but is no longer deemed so, informed consent must be obtained from the subject?s legally acceptable representative, and assent from the subject, if possible, will be confirmed in accordance with state and/or local regulations prior to the initiation of any trial protocol-required procedures. - If the subject is deemed incapable by the investigator of providing consent (eg, subjects with severe dementia), written informed consent will be obtained from the subject?s legally acceptable representative prior to initiation of any trial protocol-required procedures. In such cases, assent from the subject, if possible, will be confirmed in accordance with state and/or local regulations prior to the initiation of any trial protocol-required procedures. - If the subject cannot provide assent, and does not dissent, then the consent of the legally acceptable representative is sufficient unless otherwise required by the governing ethics body and/or applicable state and/or local regulations. - If the subject dissents, then the subject is not eligible for participation in the trial. - If the subject initially provided assent at trial entry, but subsequently dissents to participate in the trial, then the subject will be early terminated from the trial. - Male and female subjects who completed both the 12-week double-blind treatment period and the 30-day safety follow-up visit of Trials 283/284. - Subjects with an identified caregiver who is usually assigned to care for the subject on a regular basis, has sufficient contact to describe the subjects? symptoms, and has direct observation of the subjects? behavior. The identified caregiver will be a member of the residential facility staff or other individual (eg, family member, family friend, hired professional caregiver) who meets the caregiver requirements. - Subjects 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 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 494
Exclusion criteria
Exclusion criteria: Key exclusion criteria include the following: - Subjects who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of subjects with agitation associated with dementia of the Alzheimer?s type who were previously treated with brexpiprazole (0.5, 1, or 2 mg/day) or placebo during Trial 331-12-283 or Trial 331-12-284;Secondary Objective: Not applicable;Primary end point(s): The following safety endpoints will be evaluated during this trial. - Frequency and severity of AEs, serious AEs, and discontinuations from the trial due to AEs. - Frequency and severity of AEs related to the worsening of agitation associated with Alzheimer?s disease. - Frequency and severity of AEs related to the worsening of cognition associated with Alzheimer?s disease. - Frequency and severity of other AEs of interest (eg, falls, sedation, weight changes, or deaths). - Newly initiated concomitant medications for the treatment of agitation associated with Alzheimer?s disease. - Newly initiated concomitant medications for the treatment of cognitive symptoms associated with Alzheimer?s disease. - Mean change in the MMSE score from baseline (Week 12 MMSE from Trials 283/284) to Month 2/ET.;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Bulgaria, Canada, Croatia, Finland, France, Germany, Russian Federation, Serbia, Slovenia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactCatherine Aurang
Otsuka Pharmaceutical Development & Commercialization, Inc.
Outcome results
None listed