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

Completed · Phase 3 · Has a placebo group

Conditions studied: Agitation Associated With Alzheimer's Dementia, Alzheimer Dementia

In brief

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

Key facts

Study ID

NCT03548584

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

345

Starts

2018-05-16

Expected to finish

2022-06-01

Last updated by the study team

2023-09-18

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• For additional information regarding sites, contact 844-687-8522 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.