Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Completed · Phase 3 · Has a placebo group

Conditions studied: Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases

In brief

To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

Key facts

Study ID

NCT01922258

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

270

Starts

2013-09-01

Expected to finish

2017-03-01

Last updated by the study team

2020-11-20

Who can join

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

You may qualify if…

• Male and female subjects 55 to 90 years of age, inclusive, at the time of informed consent.
• Subjects who are residing at their current location for at least 14 days before screening and are expected to remain at the same location for the duration of the trial.
• Subjects with diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria.
• Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
• Subjects with onset of symptoms of agitation at least 2 weeks prior to the screening visit.
• Subjects with a total score greater than or equal to 4 on the agitation aggression item of the NPI-NH or NPI/NPI-NH at the screening and baseline visits.
• Subjects who require pharmacotherapy for the treatment of agitation per the investigator's judgement, after an evaluation of reversible factors (eg, pain, infection, polypharmacy) and a trial of nonpharmacological interventions.
• Subjects must have a previous MRI or CT scan of the brain, which was performed after the onset of symptoms of dementia, with findings consistent with the diagnosis of Alzheimer's disease.

You may not qualify if…

• Subjects with dementia or other memory impairment not due to Alzheimer's disease.
• Subjects with history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
• Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
• Subjects who have been diagnosed with an Axis I disorder (DSM-IV-TR criteria).
• Subjects with uncontrolled hypertension.
• Subjects with uncontrolled insulin-dependent diabetes mellitus (IDDM)
• Subjects with epilepsy or a history of seizures.
• Subjects considered in poor general health based on the investigator's judgment.

Where it is running

• Study site — Lakewood, California, United States
• Study site — Long Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Panorama City, California, United States
• Study site — Universal City, California, United States
• Study site — Denver, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Quincy, Massachusetts, United States
• Study site — South Dartmouth, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Brooklyn, New York, United States
• Study site — Buffalo, New York, United States
• Study site — New Hyde Park, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Imperial, California, United States

Full record on ClinicalTrials.gov

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