Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01922258 ↗
Enrolled (actual)
270
Serious AEs
4.8%
Results posted
Jul 2020
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
11citations · ~6 / year
Defining a clinically meaningful within-patient change threshold for the Cohen-Mansfield Agitation Inventory in Alzheimer's dementia.
Summary
To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type
Linked Publications (5)
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Defining a clinically meaningful within-patient change threshold for the Cohen-Mansfield Agitation Inventory in Alzheimer's dementia.
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Safety and Tolerability of Brexpiprazole in Participants with Agitation Associated with Dementia due to Alzheimer's Disease: Pooled Analysis of Three Randomized Trials and an Extension Trial.
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Efficacy of Brexpiprazole in Participants with Agitation Associated with Dementia Due to Alzheimer's Disease: Pooled Analysis of Randomized Controlled Trials.
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Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer's Disease: Timing and Duration of Adverse Events.
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Brexpiprazole side-effect profile in people with agitation in Alzheimer's dementia: a plain language summary.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.