Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2025
Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia.
Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03620981 (A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Who cites it
2 citing papers in PubMed.
- Efficacy of Brexpiprazole on Neuropsychiatric Symptoms and Impact on Caregivers: Pooled Neuropsychiatric Inventory (NPI) Analysis in Patients With Agitation Associated With Dementia due to Alzheimer's Disease.Journal of geriatric psychiatry and neurology · 2026Trial
- Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
introductionWe evaluated the impacts of brexpiprazole treatment on patient neuropsychiatric symptoms and caregiver distress in Japanese patients with agitation in Alzheimer's dementia (AAD).
methodsIn a phase 2/3 multicenter, double-blind study, patients were randomized to receive brexpiprazole 1 or 2 mg/day, or placebo (3:4:4) for 10 weeks. The Neuropsychiatric Inventory (NPI) was used for evaluation. The areas of patient symptoms and caregiver distress were defined as NPI and NPI-Distress, respectively.
resultsAt Week 10, the differences of brexpiprazole 1 and 2 mg versus placebo for NPI total score were -1.2 (p = 0.5891) and -8.4 (p < 0.0001), and those for NPI-Distress total score were -1.1 (p = 0.2292) and -3.9 (p < 0.0001), respectively. In brexpiprazole 2 mg versus placebo, NPI and NPI-Distress agitation/aggression score showed ≥ 2 and ≥ 1 point improvement, respectively. DISCUSSION: Brexpiprazole is suggested to improve patient symptoms and to reduce caregiver distress in the treatment of AAD in Japanese patients.
trial registrationClinicalTrials.gov Identifier NCT03620981 HIGHLIGHTS: Brexpiprazole improved symptoms of patients with agitation in Alzheimer's dementia. The improvements included not only agitation, but also various behavioral and psychological symptoms of dementia scores. The improvements of patient symptoms led to the reduction of caregiver distress. Our study suggests that brexpiprazole is beneficial for both patients and caregivers.
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Registered trials
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