Clinical trial NCT03548584: A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
Official title: A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Agitation Associated With Alzheimer's Dementia
Alzheimer Dementia
Keywords: Agitation
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2018-06-07
Enrollment: 345
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

Detailed description: 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 participants 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 participant is not living alone. This trial will analyze data gathered from approximately 330 participants at multiple countries. Participants may also be eligible to enter an active treatment extension trial.

Eligibility criteria: Inclusion Criteria:

* Participants with a diagnosis of probable Alzheimer's disease.
* Participants with a diagnosis of agitation
* Participants with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
* Participants with a previous MRI or CT scan of the brain, that was performed after the onset of symptoms of dementia, with findings consistent with a diagnosis of Alzheimer's disease.
* Participants who are residing at their current location for at least 28 days before screening and are expected to remain at the same location for the duration of the trial.
* Institutionalized participants with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the participant's symptoms and has direct observation of the participant's behavior. Non-institutionalized participants 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 participant's symptoms and has direct observation of the participant's behavior.
* Participants with onset of symptoms of agitation at least 2 weeks prior to screening visit.
* Participants will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.

Exclusion Criteria:

* Participants with dementia or other memory impairment not due to Alzheimer's disease.
* Participants with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
* Participants who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
* Participants who have been diagnosed with an Axis I disorder.
* Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
* Participants with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
* Participants with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.

Primary outcomes:
measure: Change From Baseline to Week 12 in the CMAI Total Score
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Agitation
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in CMAI Subscale Scores
timeFrame: Baseline and Week 12
measure: Change From Baseline in CMAI Total Score for Each Trial Visit During the Double-blind Treatment Period
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 12
measure: Change From Baseline in CGI-S for Each Trial Visit During the Double-Blind Treatment Period
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 12
measure: Clinical Global Impressions-Improvement (CGI-I) Score at Each Trial Visit During the Double-Blind Treatment Period
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 12
measure: CMAI Response Rate Assessed as Percentage of Participants With CMAI Response at Every Scheduled Trial Visit in the Double-Blind Treatment Period
timeFrame: Weeks 2, 4, 6, 8, 10, and 12
measure: CMAI Response Rate Assessed as Percentage of Participants With CMAI Response Based on Improvement From Baseline in Agitation Status at Every Scheduled Trial Visit in the Double-Blind Treatment Period
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 12
measure: CGI-I Response Rate Assessed as Percentage of Participants With CGI-I Response at Every Scheduled Trial Visit in the Double-Blind Treatment Period
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: California
Study officials:
References: