Phase 3
N=270
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Agitation Associated With · Alzheimer's Disease · Alzheimer's Type · Mental Disorder · Nervous System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01922258 ↗Enrolled (actual)
270
Serious AEs
4.8%
Results posted
Jul 2020
Primary outcome: Primary: Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score — -18.9; -16.5 units on a scale — p==0.1454
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole, OPC-34712 (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score |
-18.9; -16.5 | =0.1454 |
| SECONDARY Change in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Symptoms of Agitation |
4.54; 4.51 | — |
Summary
To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01922258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.