Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.

<h4>Background</h4>Agitation in Alzheimer's disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Chris Fox, Monica Crugel, Ian Maidment, Bjorn Henrik Auestad, Simon Coulton, Adrian Treloar, Clive Ballard, Malaz Boustani, Cornelius Katona, Gill Livingston
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2012
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/a3d8c3e29aee45faa42cf52f69ff9836
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:a3d8c3e29aee45faa42cf52f69ff9836
record_format	dspace
spelling	oai:doaj.org-article:a3d8c3e29aee45faa42cf52f69ff98362021-11-18T07:19:59ZEfficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.1932-620310.1371/journal.pone.0035185https://doaj.org/article/a3d8c3e29aee45faa42cf52f69ff98362012-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/22567095/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>Agitation in Alzheimer's disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD.<h4>Methods and findings</h4>We recruited 153 participants with AD and clinically significant agitation from care-homes or hospitals for a double-blind randomised-controlled trial and 149 people started the trial of memantine versus placebo. The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory (CMAI). Secondary outcomes were: 12 weeks CMAI; 6 and 12 weeks Neuropsychiatric symptoms (NPI), Clinical Global Impression Change (CGI-C), Standardised Mini Mental State Examination, Severe Impairment Battery. Using a mixed effects model we found no significant differences in the primary outcome, 6 weeks CMAI, between memantine and placebo (memantine lower -3.0; -8.3 to 2.2, p = 0.26); or 12 weeks CMAI; or CGI-C or adverse events at 6 or 12 weeks. NPI mean difference favoured memantine at weeks 6 (-6.9; -12.2 to -1.6; p = 0.012) and 12 (-9.6; -15.0 to -4.3 p = 0.0005). Memantine was significantly better than placebo for cognition. The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD.<h4>Conclusions</h4>Memantine did not improve significant agitation in people with in moderate-to-severe AD. Future studies are urgently needed to test other pharmacological candidates in this group and memantine for neuropsychiatric symptoms.<h4>Trial registration</h4>ClinicalTrials.gov NCT00371059.<h4>Trial registration</h4>International Standard Randomised Controlled Trial 24953404.Chris FoxMonica CrugelIan MaidmentBjorn Henrik AuestadSimon CoultonAdrian TreloarClive BallardMalaz BoustaniCornelius KatonaGill LivingstonPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 7, Iss 5, p e35185 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Chris Fox Monica Crugel Ian Maidment Bjorn Henrik Auestad Simon Coulton Adrian Treloar Clive Ballard Malaz Boustani Cornelius Katona Gill Livingston Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.
description	<h4>Background</h4>Agitation in Alzheimer's disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD.<h4>Methods and findings</h4>We recruited 153 participants with AD and clinically significant agitation from care-homes or hospitals for a double-blind randomised-controlled trial and 149 people started the trial of memantine versus placebo. The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory (CMAI). Secondary outcomes were: 12 weeks CMAI; 6 and 12 weeks Neuropsychiatric symptoms (NPI), Clinical Global Impression Change (CGI-C), Standardised Mini Mental State Examination, Severe Impairment Battery. Using a mixed effects model we found no significant differences in the primary outcome, 6 weeks CMAI, between memantine and placebo (memantine lower -3.0; -8.3 to 2.2, p = 0.26); or 12 weeks CMAI; or CGI-C or adverse events at 6 or 12 weeks. NPI mean difference favoured memantine at weeks 6 (-6.9; -12.2 to -1.6; p = 0.012) and 12 (-9.6; -15.0 to -4.3 p = 0.0005). Memantine was significantly better than placebo for cognition. The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD.<h4>Conclusions</h4>Memantine did not improve significant agitation in people with in moderate-to-severe AD. Future studies are urgently needed to test other pharmacological candidates in this group and memantine for neuropsychiatric symptoms.<h4>Trial registration</h4>ClinicalTrials.gov NCT00371059.<h4>Trial registration</h4>International Standard Randomised Controlled Trial 24953404.
format	article
author	Chris Fox Monica Crugel Ian Maidment Bjorn Henrik Auestad Simon Coulton Adrian Treloar Clive Ballard Malaz Boustani Cornelius Katona Gill Livingston
author_facet	Chris Fox Monica Crugel Ian Maidment Bjorn Henrik Auestad Simon Coulton Adrian Treloar Clive Ballard Malaz Boustani Cornelius Katona Gill Livingston
author_sort	Chris Fox
title	Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.
title_short	Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.
title_full	Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.
title_fullStr	Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.
title_full_unstemmed	Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.
title_sort	efficacy of memantine for agitation in alzheimer's dementia: a randomised double-blind placebo controlled trial.
publisher	Public Library of Science (PLoS)
publishDate	2012
url	https://doaj.org/article/a3d8c3e29aee45faa42cf52f69ff9836
work_keys_str_mv	AT chrisfox efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT monicacrugel efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT ianmaidment efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT bjornhenrikauestad efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT simoncoulton efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT adriantreloar efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT cliveballard efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT malazboustani efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT corneliuskatona efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial AT gilllivingston efficacyofmemantineforagitationinalzheimersdementiaarandomiseddoubleblindplacebocontrolledtrial
_version_	1718423616455966720

Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.

Ejemplares similares