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Randomized Controlled Trial
. 2019 Apr 11;19(1):101.
doi: 10.1186/s12877-019-1122-2.

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)

Aina Soler  1   2 , Guillem Amer  3 , Alicia Leiva  4   5 , Joana Ripoll  4   5 , María Angeles Llorente  6 , Alfonso Leiva  4   5 , Joana Maria Taltavull  4   5 , Rosa Molina  7 , Joan Llobera  4   5
Affiliations
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)

Aina Soler et al. BMC Geriatr. .

Abstract

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 12 months 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 12 months. 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.

Trial registration: The study was prospectively registered in the REec (2017-000042-22) on May 11 2017 and ID ISRCTN12134230 on February 25 2019.

Keywords: Cholinesterase inhibitors; Dementia; Deprescription; Randomized controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

This study will follow the principles outlined in the Declaration of Helsinki (with the Tokyo 2004 amendment). All legal caregivers and patient when appropriate will provide written informed consent, and will be told that participation is voluntary and can be withdrawn at any time without any negative consequences concerning current or future medical treatments. Ethical approval was provided by the Primary Care Research Commission (PI16/025), the Institutional Review Board of the Balearic Islands Health Service (CEI-IB Ref. No: PI16/720), and the Spanish Agency on Drugs and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios [AEMPS]) (EudraCT number 2017–000042-22). Approved protocol version 2.0 (02/11/ 2016).

Any protocol amendments will be notified to Institutional Review Board of the Balearic Islands Health Service and Spanish Agency on Drugs and Medical Devices.

Consent for publication

Not Applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

References

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