Artículo
The safe, tolerability, and efficacy of once-daily memantine (28mg): a multinational, randomized, placebo-controlled trial in patients with moderate to severe Alzheimer's disease taking cholinesterase inhibitor
Grossberg, George T.; Manes, Facundo Francisco
; Allegri, Ricardo Francisco
; Gutiérrez Robledo, Luis Miguel; Gloger, Sergio; Xie, Lei; Jia, X. Daniel; Pejoviç, Vojislav; Miller, Michel L.; Perhach, James; Graham, Stephen M.
![Icon](/themes/CONICETDigital/images/conicet.png)
![Icon](/themes/CONICETDigital/images/conicet.png)
Fecha de publicación:
06/2013
Editorial:
Springer
Revista:
Cns Drugs
ISSN:
1172-7047
e-ISSN:
1179-1934
Idioma:
Inglés
Tipo de recurso:
Artículo publicado
Clasificación temática:
Resumen
INTRODUCTION: Immediate-release memantine (10 mg, twice daily) is approved in the USA for moderate-to-severe Alzheimer's disease (AD). This study evaluated the efficacy, safety, and tolerability of a higher-dose, once-daily, extended-release formulation in patients with moderate-to-severe AD concurrently taking cholinesterase inhibitors. METHODS: In this 24-week, double-blind, multinational study (NCT00322153), outpatients with AD (Mini-Mental State Examination scores of 3-14) were randomized to receive once-daily, 28-mg, extended-release memantine or placebo. Co-primary efficacy parameters were the baseline-to-endpoint score change on the Severe Impairment Battery (SIB) and the endpoint score on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus). The secondary efficacy parameter was the baseline-to-endpoint score change on the 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19); additional parameters included the baseline-to-endpoint score changes on the Neuropsychiatric Inventory (NPI) and verbal fluency test. Data were analyzed using a two-way analysis of covariance model, except for CIBIC-Plus (Cochran-Mantel-Haenszel test). Safety and tolerability were assessed through adverse events and physical and laboratory examinations. RESULTS: A total of 677 patients were randomized to receive extended-release memantine (n = 342) or placebo (n = 335); completion rates were 79.8 and 81.2 %, respectively. At endpoint (week 24, last observation carried forward), memantine-treated patients significantly outperformed placebo-treated patients on the SIB (least squares mean difference [95 % CI] 2.6 [1.0, 4.2]; p = 0.001), CIBIC-Plus (p = 0.008), NPI (p = 0.005), and verbal fluency test (p = 0.004); the effect did not achieve significance on ADCS-ADL19 (p = 0.177). Adverse events with a frequency of ≥5.0 % that were more prevalent in the memantine group were headache (5.6 vs. 5.1 %) and diarrhea (5.0 vs. 3.9 %). CONCLUSION: Extended-release memantine was efficacious, safe, and well tolerated in this population.
Palabras clave:
Alzheimer
,
Memantine
,
Trial
,
Once-Daily
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Articulos de SEDE CENTRAL
Articulos de SEDE CENTRAL
Citación
Grossberg, George T.; Manes, Facundo Francisco; Allegri, Ricardo Francisco; Gutiérrez Robledo, Luis Miguel; Gloger, Sergio; et al.; The safe, tolerability, and efficacy of once-daily memantine (28mg): a multinational, randomized, placebo-controlled trial in patients with moderate to severe Alzheimer's disease taking cholinesterase inhibitor; Springer; Cns Drugs; 27; 6; 6-2013; 469-478
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