Phase 3
N=345
A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
Agitation Associated With Alzheimer's Dementia · Alzheimer Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03548584 ↗Enrolled (actual)
345
Serious AEs
2.6%
Results posted
Sep 2023
Primary outcome: Primary: Change From Baseline to Week 12 in the CMAI Total Score — -22.6; -17.3 score on a scale — p=0.0026
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in the CMAI Total Score |
-22.6; -17.3 | 0.0026 sig |
| SECONDARY Change From Baseline to Week 12 in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Agitation |
-1.20; -0.93 | 0.0078 sig |
| SECONDARY Change From Baseline to Week 12 in CMAI Subscale Scores |
-9.09; -7.13; -6.45; -5.04; -4.39; -3.14 | 0.0040 sig |
| SECONDARY Change From Baseline in CMAI Total Score for Each Trial Visit During the Double-blind Treatment Period |
-5.76; -6.61; -12.1; -11.0; -16.2; -13.9 | 0.4242 |
| SECONDARY Change From Baseline in CGI-S for Each Trial Visit During the Double-Blind Treatment Period |
-0.21; -0.27; -0.53; -0.50; -0.74; -0.68 | 0.3048 |
| SECONDARY Clinical Global Impressions-Improvement (CGI-I) Score at Each Trial Visit During the Double-Blind Treatment Period |
3.70; 3.57; 3.19; 3.39; 2.92; 3.19 | 0.1975 |
| SECONDARY CMAI Response Rate Assessed as Percentage of Participants With CMAI Response at Every Scheduled Trial Visit in the Double-Blind Treatment Period |
11.3; 13.2; 29.3; 27.6; 43.1; 37.9 | 0.7290 |
| SECONDARY CMAI Response Rate Assessed as Percentage of Participants With CMAI Response Based on Improvement From Baseline in Agitation Status at Every Scheduled Trial Visit in the Double-Blind Treatment Period |
8.14; 14.0; 20.4; 19.0; 33.8; 26.7 | 0.1503 |
| SECONDARY CGI-I Response Rate Assessed as Percentage of Participants With CGI-I Response at Every Scheduled Trial Visit in the Double-Blind Treatment Period |
4.98; 5.26; 21.8; 12.1; 35.1; 23.3 | 0.8549 |
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.
Eligibility Criteria
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-documented transient ischemic attack, or pulmonary or cerebral embolism.
- Participants who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
- Participants who have been diagnosed with an Axis I disorder.
- Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
- Participants with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
- Participants with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.
Data sourced from ClinicalTrials.gov (NCT03548584). 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.