Long-Term Safety and Efficacy of Bapineuzumab in Patients with Mild-to-Moderate Alzheimer's Disease: A Phase 2, Open-Label Extension Study.
Curr Alzheimer Res
; 15(13): 1231-1243, 2018.
Article
en En
| MEDLINE
| ID: mdl-30129411
ABSTRACT
BACKGROUND:
Bapineuzumab is a humanized anti-amyloid-beta (Aß) monoclonal antibody directed at lowering the cerebral Aß deposit in Alzheimer's disease (AD).OBJECTIVE:
This phase 2, open-label extension (OLE) study evaluated long-term safety and efficacy of bapineuzumab in patients with the mild-to-moderate AD.METHODS:
Patients (58-78 years) who completed either of two randomized, placebo-controlled, doubleblind studies (subcutaneous [SC] single-dose-escalation, or intravenous (IV) multiple-ascending-dose)) entered the OLE. Three groups were assessed bapineuzumab or placebo SC, and bapineuzumab (IV) in OLE (bapi SC/bapi IV); bapineuzumab (IV) in Study 201 and OLE (bapi/bapi); and placebo in Study 201 and bapineuzumab IV in OLE (placebo/bapi).RESULTS:
Of 194 patients enrolled, 158 withdrew from OLE; primarily due to withdrawal by subject (n=85) and AE (n=30). Mean (SD) bapineuzumab exposure was 2.9 (1.90) years. There were no significant differences for efficacy endpoints (AD Assessment Scale-cognitive subscale [ADAS-Cog], Disability Assessment for Dementia [DAD] and MMSE scores) between the bapi/bapi and placebo/bapi groups. Most patients (94.8%, 184/194) reported ≥1 treatment-emergent adverse events (TEAEs) in OLE. Amyloid-related imaging abnormalities with effusion or edema (ARIA-E) occurred in 22 (11.3%) patients. The most common TEAEs (>20% patients) were fall, agitation and urinary tract infection with similar incidences between bapi/bapi and placebo/bapi groups.CONCLUSION:
No significant difference was seen in cognitive and functional decline between early and delayed treatment groups. No new safety concerns emerged. ARIA-E incidence was higher in patients first exposed to bapineuzumab in OLE versus previously exposed. No clear pattern of etiology contributed to death events.Palabras clave
Texto completo:
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Bases de datos:
MEDLINE
Asunto principal:
Resultado del Tratamiento
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Enfermedad de Alzheimer
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Anticuerpos Monoclonales Humanizados
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Factores Inmunológicos
Tipo de estudio:
Clinical_trials
/
Etiology_studies
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Observational_studies
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Risk_factors_studies
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Curr Alzheimer Res
Asunto de la revista:
NEUROLOGIA
Año:
2018
Tipo del documento:
Article
País de afiliación:
Estados Unidos