Overview

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

Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
All
Summary
To compare the efficacy of flexible dosing 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:

- 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.

Exclusion Criteria:

- 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.