Status:
COMPLETED
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Agitation Associated With
Alzheimer's Disease
Eligibility:
All Genders
55-90 years
Phase:
PHASE3
Brief Summary
To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
Detailed Description
Behavioral symptoms, such as agitation, are core features in participants with Alzheimer's disease and related dementias and develop in the majority of dementia participants. The presence of agitation...
Eligibility Criteria
Inclusion
- Male and female participants 55 to 90 years of age, inclusive, at the time of informed consent.
- Participants 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.
- Participants with a diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association.
- Participants with a Mini-Mental State Exam score of 5 to 22, inclusive, at screening and baseline visits.
- Participants with onset of symptoms of agitation at least 2 weeks prior to the screening visit.
- Participants with a score of ≥ 4 on the agitation/aggression item of the Neuropsychiatric Inventory-Nursing Home at the screening and baseline visits.
- Participants who require pharmacotherapy for treatment of agitation per the investigator's judgment, after an evaluation for reversible factors (for example, pain, infection, polypharmacy) and a trial of nonpharmacological intervention.
- Participants must have a previous magnetic resonance imaging or computed tomography of the brain, which was performed after the onset of symptoms of dementia, with findings consistent with the diagnosis of Alzheimer's disease.
Exclusion
- Participants with dementia or other memory impairment not due to Alzheimer's disease
- Participants with a history of stroke, well-documented transient ischemic attack, pulmonary or cerebral embolism.
- Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
- Participants who have been diagnosed with an Axis I disorder (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision criteria)
- Participants with uncontrolled hypertension
- Participants with uncontrolled insulin-dependent diabetes mellitus
- Participants with epilepsy or a history of seizures
- Participants considered in poor general health based on the investigator's judgment.
Key Trial Info
Start Date :
July 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2017
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT01862640
Start Date
July 11 2013
End Date
March 15 2017
Last Update
December 31 2020
Active Locations (85)
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Tuscaloosa, Alabama, United States, 35404
2
Phoenix, Arizona, United States, 85013
3
Bellflower, California, United States, 90706
4
Costa Mesa, California, United States, 92627