A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation… (NCT03548584) | Clinical Trial Compass
CompletedPhase 3
A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
United States345 participantsStarted 2018-05-16
Plain-language summary
This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
Who can participate
Age range55 Years – 90 Years
SexALL
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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-documen…
What they're measuring
1
Change From Baseline to Week 12 in the CMAI Total Score
Timeframe: Baseline and Week 12
Trial details
NCT IDNCT03548584
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.