A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

Otsuka

Status and phase: Completed; Phase 3

Conditions: Alzheimer Dementia; Agitation Associated With Alzheimer's Dementia

Treatments: Other: Placebo; Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03548584

331-14-213

Details and patient eligibility

About

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

Full 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.

Enrollment: 345 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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345 participants in 3 patient groups, including a placebo group

Brexpiprazole 2 mg

Experimental group

Description:

Participants followed a titration schedule, to gradually increase their dose from 0.5 milligrams per day (mg/day) in the starting to 2 mg/day from Day 15. Participants continued to receive brexpiprazole 2 milligrams (mg), once daily until Week 12.

Treatment:

Drug: Brexpiprazole

Brexpiprazole 3 mg

Experimental group

Description:

Participants followed a titration schedule, to gradually increase their dose from 0.5 mg/day in the starting to 3 mg/day from Day 29. Participants continued to receive brexpiprazole 3 mg, once daily until Week 12.

Treatment:

Drug: Brexpiprazole

Placebo

Placebo Comparator group

Description:

Participants received matching placebo, once daily for 12 weeks.

Treatment:

Other: Placebo