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dc.contributor.author
Grossberg, George T.
dc.contributor.author
Manes, Facundo Francisco
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Allegri, Ricardo Francisco
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Gutiérrez Robledo, Luis Miguel
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Gloger, Sergio
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Xie, Lei
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Jia, X. Daniel
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Pejoviç, Vojislav
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Miller, Michel L.
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Perhach, James
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Graham, Stephen M.
dc.date.available
2017-09-20T19:01:47Z
dc.date.issued
2013-06
dc.identifier.citation
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
dc.identifier.issn
1172-7047
dc.identifier.uri
http://hdl.handle.net/11336/24718
dc.description.abstract
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.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Springer
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dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
Alzheimer
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Memantine
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Trial
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Once-Daily
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Reumatología
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Medicina Clínica
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dc.subject.classification
CIENCIAS MÉDICAS Y DE LA SALUD
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dc.title
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
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
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info:eu-repo/semantics/publishedVersion
dc.date.updated
2017-09-19T14:25:43Z
dc.identifier.eissn
1179-1934
dc.journal.volume
27
dc.journal.number
6
dc.journal.pagination
469-478
dc.journal.pais
Alemania
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dc.journal.ciudad
Berlín
dc.description.fil
Fil: Grossberg, George T.. Saint Louis University School of Medicine; Estados Unidos
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Fil: Manes, Facundo Francisco. Instituto de Neurología Cognitiva; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Allegri, Ricardo Francisco. Fundación para la Lucha Contra las Enfermedades Neurológicas de la Infancia. Instituto de Investigaciones Neurológicas "Raúl Carrea"; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Gutiérrez Robledo, Luis Miguel. Institutos Nacionales de Salud de México. Instituto de Geriatría; México
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Fil: Gloger, Sergio. PsicoMedica Clinical and Research Group; Chile
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Fil: Xie, Lei. Forest Research Institute; Estados Unidos
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Fil: Jia, X. Daniel. Forest Research Institute; Estados Unidos
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Fil: Pejoviç, Vojislav. Prescott Medical Communications Group; Estados Unidos
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Fil: Miller, Michel L.. Prescott Medical Communications Group; Estados Unidos
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Fil: Perhach, James. Forest Research Institute; Estados Unidos
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Fil: Graham, Stephen M.. Forest Research Institute; Estados Unidos
dc.journal.title
Cns Drugs
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dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://link.springer.com/article/10.1007%2Fs40263-013-0077-7
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info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1007/s40263-013-0077-7
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info:eu-repo/semantics/altIdentifier/url/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680656/
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