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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Brexpiprazole

Criteria

Inclusion Criteria:

• Subjects with a diagnosis of probable Alzheimer's disease.

• Subjects with a diagnosis of agitation

• Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.

• Subjects 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.

• Subjects 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 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. 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.

• Subjects with onset of symptoms of agitation at least 2 weeks prior to screening visit.

• Subjects will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.

Exclusion Criteria:

• Subjects with dementia or other memory impairment not due to Alzheimer's disease.

• Subjects with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.

• Subjects who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.

• Subjects who have been diagnosed with an Axis I disorder.

• Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.

• Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.

• Subjects with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.