Identificador para citar o enlazar este ítem: http://hdl.handle.net/20.500.13003/17397
Continuation versus discontinuation of treatment for severe dementia: randomized, pragmatic, open-label, clinical trial to evaluate the efficacy of continuing drug treatment in patients with severe dementia (STOP-DEM)
Identificadores
ISSN: 1471-2318
WOS ID: 000464838400001
Scopus EID: 2-s2.0-85064221459
PMID: 30971215
Embase PUI: L627329019
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2019-04-11Tipo de documento
research articleCitación
Soler Mieras A, Amer G, Leiva Mir A, Ripoll J, Llorente MA, Leiva A, et al. Continuation versus discontinuation of treatment for severe dementia: randomized, pragmatic, open-label, clinical trial to evaluate the efficacy of continuing drug treatment in patients with severe dementia (STOP-DEM). BMC Geriatr. 2019 Apr 11;19:101.Resumen
Background; Previous observational studies and clinical trials have shown that cholinesterase inhibitors (with or without memantine) provide benefit for patients with mild-to-moderate Alzheimer's disease. However, the impact of treatment continuation after progression to severe disease is unknown. The main aim of this study is to evaluate the effect and safety of continuing treatment with ChEIs (with or without memantine) for patients with severe dementia. Methods: This randomized, pragmatic, open-label clinical trial with blinded evaluators will evaluate the efficacy of continuing drug treatment in patients with advanced dementia. A total of 302 community-dwelling patients with severe dementia, Alzheimer's disease, with or without a coexisting diagnosis of vascular dementia, and a score of 10 or less on the Mini-Mental State Examination who received previous treatment with a cholinesterase inhibitor (with or without memantine) for at least 3 months, will be randomized to continue or discontinue drug treatment. Follow-up will be 12months or until the primary endpoint is achieved. The primary endpoint is entry into institutional care and progression of disability, defined as a loss of 2 of 4 basic functions, or 6 of 11 instrumental functions, according to the Bristol Activities of Daily Living Scale at 12months. The secondary outcomes are patient changes in functional and cognitive state, quality of life, and caregiver burden. Discussion: We expect that the results of our study will allow to identify if there is clinical relevant impact for patients and caregivers between maintaining or halting pharmacological treatment.
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https://dx.doi.org/10.1186/s12877-019-1122-2MeSH
DementiaAged, 80 and over
Activities of Daily Living
Aged
Cholinesterase Inhibitors
Humans
Memantine
Withholding Treatment
Male
Quality of Life
Severity of Illness Index
Female
Treatment Outcome
Single-Blind Method
DeCS
Resultado del TratamientoMétodo Simple Ciego
Femenino
Masculino
Privación de Tratamiento
Memantina
Humanos
Calidad de Vida
Actividades Cotidianas
Anciano
Inhibidores de la Colinesterasa
Índice de Severidad de la Enfermedad
Anciano de 80 o más Años
Demencia
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Instituto de Investigación Sanitaria Islas Baleares - IDISBA > Comunicación científica