Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease.
Int Psychogeriatr
; 25(5): 707-19, 2013 May.
Article
em En
| MEDLINE
| ID: mdl-23257314
ABSTRACT
BACKGROUND:
Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer's disease (AD).METHODS:
Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer's Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored.RESULTS:
Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group.CONCLUSION:
Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues. This trial is registered on ClinicalTrials.gov; ID NCT00843518.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Agitação Psicomotora
/
Sulfonamidas
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Compostos de Bifenilo
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Agressão
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Doença de Alzheimer
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Prognostic_studies
Limite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article