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Efficacy of Brexpiprazole Across Agitation Behaviors in Alzheimer's Disease, Including Impact on Caregivers, Analyzed Using the Neuropsychiatric Inventory: A Post Hoc Pooled Analysis of Randomized, Fixed-Dose, Placebo-Controlled Trials
Agitation symptoms are prevalent clinical manifestations of dementia due to Alzheimer's disease and are among the most difficult and stressful aspects of the disease for patients and caregivers. The presence of agitation symptoms in patients with dementia due to Alzheimer's disease is link...
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Published in: | The American journal of geriatric psychiatry 2024-04, Vol.32 (4), p.S92-S93 |
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Main Authors: | , , , , , , , |
Format: | Article |
Language: | English |
Online Access: | Get full text |
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Summary: | Agitation symptoms are prevalent clinical manifestations of dementia due to Alzheimer's disease and are among the most difficult and stressful aspects of the disease for patients and caregivers. The presence of agitation symptoms in patients with dementia due to Alzheimer's disease is linked to a greater negative impact on caregivers. This post hoc analysis explored changes in neuropsychiatric symptoms (including agitation) and impact on caregivers, in patients with agitation associated with dementia due to Alzheimer's disease, treated with brexpiprazole.
This is a pooled post hoc analysis of two 12-week, Phase 3, randomized, placebo-controlled trials of fixed-dose brexpiprazole in patients with agitation associated with dementia due to Alzheimer's disease (NCT01862640; NCT03548584). In each study, the Neuropsychiatric Inventory (NPI) Nursing Home version (NPI-NH; institutionalized patients), or the neuropsychiatric assessment for non-institutionalized patients based on the NPI-NH, was assessed. The NPI is evaluated via caregiver interview and comprises 12 domains (neuropsychiatric symptoms), which are scored from best to worst on frequency (1 to 4), severity (1 to 3), and occupational disruptiveness (institutionalized)/caregiver distress (non-institutionalized) (0 to 5). The present analysis evaluated pooled data from the two fixed-dose trials (data for institutionalized and non-institutionalized patients) for the following outcomes: NPI total (sum of frequency x severity for the 12 domains), NPI agitation/aggression domain, NPI occupational disruptiveness/caregiver distress (total, and in the agitation/aggression domain), NPI-4A subscale (agitation/aggression, irritability/lability, aberrant motor behavior, and anxiety domains), and NPI-4D subscale (agitation/aggression, irritability/lability, aberrant motor behavior, and disinhibition domains). Change from baseline was analyzed using a mixed model for repeated measures. A hierarchical clustering analysis of the 12 NPI domains and NPI occupational disruptiveness/caregiver distress was also carried out.
A total of 610 patients were included in the present analysis, who received either brexpiprazole 2 or 3 mg/day (n=363) or placebo (n=247). Brexpiprazole demonstrated greater reductions versus placebo on all NPI outcome scores at Week 12: NPI total (p=0.0003), NPI agitation/aggression domain (p=0.0083), total NPI occupational disruptiveness/caregiver distress (p=0.0006), NPI occupational disruptiveness/care |
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ISSN: | 1064-7481 1545-7214 |
DOI: | 10.1016/j.jagp.2024.01.174 |