Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.

<h4>Background</h4>Mild cognitive impairment (MCI) refers to a transitional zone between normal ageing and dementia. Despite the uncertainty regarding the definition of MCI as a clinical entity, clinical trials have been conducted in the attempt to study the role of cholinesterase inhibi...

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Autores principales:	Roberto Raschetti, Emiliano Albanese, Nicola Vanacore, Marina Maggini
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2007
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/5877d46e95784f1c9c1d6c47a7760ce7
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spelling	oai:doaj.org-article:5877d46e95784f1c9c1d6c47a7760ce72021-11-25T05:37:10ZCholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.1549-12771549-167610.1371/journal.pmed.0040338https://doaj.org/article/5877d46e95784f1c9c1d6c47a7760ce72007-11-01T00:00:00Zhttps://doi.org/10.1371/journal.pmed.0040338https://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>Mild cognitive impairment (MCI) refers to a transitional zone between normal ageing and dementia. Despite the uncertainty regarding the definition of MCI as a clinical entity, clinical trials have been conducted in the attempt to study the role of cholinesterase inhibitors (ChEIs) currently approved for symptomatic treatment of mild to moderate Alzheimer disease (AD), in preventing progression from MCI to AD. The objective of this review is to assess the effects of ChEIs (donepezil, rivastigmine, and galantamine) in delaying the conversion from MCI to Alzheimer disease or dementia.<h4>Methods and findings</h4>The terms "donepezil", "rivastigmine", "galantamine", and "mild cognitive impairment" and their variants, synonyms, and acronyms were used as search terms in four electronic databases (MEDLINE, EMBASE, Cochrane, PsycINFO) and three registers: the Cochrane Collaboration Trial Register, Current Controlled Trials, and ClinicalTrials.gov. Published and unpublished studies were included if they were randomized clinical trials published (or described) in English and conducted among persons who had received a diagnosis of MCI and/or abnormal memory function documented by a neuropsychological assessment. A standardized data extraction form was used. The reporting quality was assessed using the Jadad scale. Three published and five unpublished trials met the inclusion criteria (three on donepezil, two on rivastigmine, and three on galantamine). Enrolment criteria differed among the trials, so the study populations were not homogeneous. The duration of the trials ranged from 24 wk to 3 y. No significant differences emerged in the probability of conversion from MCI to AD or dementia between the treated groups and the placebo groups. The rate of conversion ranged from 13% (over 2 y) to 25% (over 3 y) among treated patients, and from 18% (over 2 y) to 28% (over 3 y) among those in the placebo groups. Only for two studies was it possible to derive point estimates of the relative risk of conversion: 0.85 (95% confidence interval 0.64-1.12), and 0.84 (0.57-1.25). Statistically significant differences emerged for three secondary end points. However, when adjusting for multiple comparisons, only one difference remained significant (i.e., the rate of atrophy in the whole brain).<h4>Conclusions</h4>The use of ChEIs in MCI was not associated with any delay in the onset of AD or dementia. Moreover, the safety profile showed that the risks associated with ChEIs are not negligible. The uncertainty regarding MCI as a clinical entity raises the question as to the scientific validity of these trials.Roberto RaschettiEmiliano AlbaneseNicola VanacoreMarina MagginiPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 4, Iss 11, p e338 (2007)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Roberto Raschetti Emiliano Albanese Nicola Vanacore Marina Maggini Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.
description	<h4>Background</h4>Mild cognitive impairment (MCI) refers to a transitional zone between normal ageing and dementia. Despite the uncertainty regarding the definition of MCI as a clinical entity, clinical trials have been conducted in the attempt to study the role of cholinesterase inhibitors (ChEIs) currently approved for symptomatic treatment of mild to moderate Alzheimer disease (AD), in preventing progression from MCI to AD. The objective of this review is to assess the effects of ChEIs (donepezil, rivastigmine, and galantamine) in delaying the conversion from MCI to Alzheimer disease or dementia.<h4>Methods and findings</h4>The terms "donepezil", "rivastigmine", "galantamine", and "mild cognitive impairment" and their variants, synonyms, and acronyms were used as search terms in four electronic databases (MEDLINE, EMBASE, Cochrane, PsycINFO) and three registers: the Cochrane Collaboration Trial Register, Current Controlled Trials, and ClinicalTrials.gov. Published and unpublished studies were included if they were randomized clinical trials published (or described) in English and conducted among persons who had received a diagnosis of MCI and/or abnormal memory function documented by a neuropsychological assessment. A standardized data extraction form was used. The reporting quality was assessed using the Jadad scale. Three published and five unpublished trials met the inclusion criteria (three on donepezil, two on rivastigmine, and three on galantamine). Enrolment criteria differed among the trials, so the study populations were not homogeneous. The duration of the trials ranged from 24 wk to 3 y. No significant differences emerged in the probability of conversion from MCI to AD or dementia between the treated groups and the placebo groups. The rate of conversion ranged from 13% (over 2 y) to 25% (over 3 y) among treated patients, and from 18% (over 2 y) to 28% (over 3 y) among those in the placebo groups. Only for two studies was it possible to derive point estimates of the relative risk of conversion: 0.85 (95% confidence interval 0.64-1.12), and 0.84 (0.57-1.25). Statistically significant differences emerged for three secondary end points. However, when adjusting for multiple comparisons, only one difference remained significant (i.e., the rate of atrophy in the whole brain).<h4>Conclusions</h4>The use of ChEIs in MCI was not associated with any delay in the onset of AD or dementia. Moreover, the safety profile showed that the risks associated with ChEIs are not negligible. The uncertainty regarding MCI as a clinical entity raises the question as to the scientific validity of these trials.
format	article
author	Roberto Raschetti Emiliano Albanese Nicola Vanacore Marina Maggini
author_facet	Roberto Raschetti Emiliano Albanese Nicola Vanacore Marina Maggini
author_sort	Roberto Raschetti
title	Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.
title_short	Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.
title_full	Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.
title_fullStr	Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.
title_full_unstemmed	Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.
title_sort	cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.
publisher	Public Library of Science (PLoS)
publishDate	2007
url	https://doaj.org/article/5877d46e95784f1c9c1d6c47a7760ce7
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Cholinesterase inhibitors in mild cognitive impairment: a systematic review of randomised trials.

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