2026-04-29T04:09:59Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/226532024-11-29T07:35:19Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16967

00925njm 22002777a 4500 dc Soler Mieras, Aina author Amer Ferrer, Guillermo author Leiva, Alicia author Ripoll Amengual, Joana author Llorente, Maria Angeles author Leiva Rus, Alfonso author Taltavull Aparicio, Joana Maria author Molina, Rosa author Llobera Cànaves, Joan author 2019-04-11 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. 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. 1471-2318 http://hdl.handle.net/20.500.13003/17397 https://hdl.handle.net/20.500.12105/22653 30971215 10.1186/s12877-019-1122-2 BMC Geriatrics 2-s2.0-85064221459 464838400001 L627329019 Dementia Cholinesterase inhibitors Deprescription Randomized controlled trial 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)