The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design
Abstract Background Progressive neurodegeneration in Alzheimer’s disease (AD) induces cognitive deterioration, and there is controversy regarding the optimal treatment strategy in early AD. Stimulation therapy, including physical exercise and cholinesterase inhibitors are both reported to postpone c...
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ftdoajarticles:oai:doaj.org/article:5e9c4ca3c2354bf89d2cf7010138aace 2023-05-15T17:43:38+02:00 The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design Andersen Fred Viitanen Matti Halvorsen Dag S Straume Bjørn Wilsgaard Tom Engstad Torgeir A 2012-07-01T00:00:00Z https://doi.org/10.1186/1471-2377-12-59 https://doaj.org/article/5e9c4ca3c2354bf89d2cf7010138aace EN eng BMC http://www.biomedcentral.com/1471-2377/12/59 https://doaj.org/toc/1471-2377 doi:10.1186/1471-2377-12-59 1471-2377 https://doaj.org/article/5e9c4ca3c2354bf89d2cf7010138aace BMC Neurology, Vol 12, Iss 1, p 59 (2012) Alzheimer’s disease Symptomatic treatment Postponement of cognitive deterioration Neurology. Diseases of the nervous system RC346-429 article 2012 ftdoajarticles https://doi.org/10.1186/1471-2377-12-59 2022-12-31T05:51:25Z Abstract Background Progressive neurodegeneration in Alzheimer’s disease (AD) induces cognitive deterioration, and there is controversy regarding the optimal treatment strategy in early AD. Stimulation therapy, including physical exercise and cholinesterase inhibitors are both reported to postpone cognitive deterioration in separate studies. We aimed to study the effect of stimulation therapy and the additional effect of donepezil on cognitive function in early AD. Method Design: A two-by-two factorial trial comprising stimulation therapy for one year compared to standard care to which a randomized double-blinded placebo controlled trial with donepezil was added. Setting: Nine rural municipalities in Northern Norway. Participants: 187 participants 65 years and older with a recent diagnosis of mild or moderate AD were included in the study of which 146 completed a one-year follow-up. INTERVENTIONS: In five municipalities the participants received stimulation therapy whereas participants in four received standard care. All participants were randomised double-blindly to donepezil or placebo and tested with three different cognitive tests four times during the one-year study period. Main outcome: Changes in MMSE sum score. Secondary outcome: Changes in ADAS-Cog and Clock Drawing Test. Results MMSE scores remained unchanged amongst AD participants receiving stimulation therapy and those receiving standard care. The results were consistent for ADAS-Cog and Clock Drawing Test. No time trend differences were found during one-year follow-up between groups receiving stimulation therapy versus standard care or between donepezil versus placebo. Conclusion In rural AD patients non-pharmacological and pharmacological therapy did not improve outcome compared with standard care but all groups retained cognitive function during one year follow-up. Other studies are needed to confirm these results. Trial registration ClinicalTrials.gov (Identifier: NCT00443014). EudraCT database (no 2004-002613-37). Article in Journal/Newspaper Northern Norway Directory of Open Access Journals: DOAJ Articles Norway BMC Neurology 12 1 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
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English |
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Alzheimer’s disease Symptomatic treatment Postponement of cognitive deterioration Neurology. Diseases of the nervous system RC346-429 |
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Alzheimer’s disease Symptomatic treatment Postponement of cognitive deterioration Neurology. Diseases of the nervous system RC346-429 Andersen Fred Viitanen Matti Halvorsen Dag S Straume Bjørn Wilsgaard Tom Engstad Torgeir A The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design |
topic_facet |
Alzheimer’s disease Symptomatic treatment Postponement of cognitive deterioration Neurology. Diseases of the nervous system RC346-429 |
description |
Abstract Background Progressive neurodegeneration in Alzheimer’s disease (AD) induces cognitive deterioration, and there is controversy regarding the optimal treatment strategy in early AD. Stimulation therapy, including physical exercise and cholinesterase inhibitors are both reported to postpone cognitive deterioration in separate studies. We aimed to study the effect of stimulation therapy and the additional effect of donepezil on cognitive function in early AD. Method Design: A two-by-two factorial trial comprising stimulation therapy for one year compared to standard care to which a randomized double-blinded placebo controlled trial with donepezil was added. Setting: Nine rural municipalities in Northern Norway. Participants: 187 participants 65 years and older with a recent diagnosis of mild or moderate AD were included in the study of which 146 completed a one-year follow-up. INTERVENTIONS: In five municipalities the participants received stimulation therapy whereas participants in four received standard care. All participants were randomised double-blindly to donepezil or placebo and tested with three different cognitive tests four times during the one-year study period. Main outcome: Changes in MMSE sum score. Secondary outcome: Changes in ADAS-Cog and Clock Drawing Test. Results MMSE scores remained unchanged amongst AD participants receiving stimulation therapy and those receiving standard care. The results were consistent for ADAS-Cog and Clock Drawing Test. No time trend differences were found during one-year follow-up between groups receiving stimulation therapy versus standard care or between donepezil versus placebo. Conclusion In rural AD patients non-pharmacological and pharmacological therapy did not improve outcome compared with standard care but all groups retained cognitive function during one year follow-up. Other studies are needed to confirm these results. Trial registration ClinicalTrials.gov (Identifier: NCT00443014). EudraCT database (no 2004-002613-37). |
format |
Article in Journal/Newspaper |
author |
Andersen Fred Viitanen Matti Halvorsen Dag S Straume Bjørn Wilsgaard Tom Engstad Torgeir A |
author_facet |
Andersen Fred Viitanen Matti Halvorsen Dag S Straume Bjørn Wilsgaard Tom Engstad Torgeir A |
author_sort |
Andersen Fred |
title |
The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design |
title_short |
The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design |
title_full |
The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design |
title_fullStr |
The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design |
title_full_unstemmed |
The effect of stimulation therapy and donepezil on cognitive function in Alzheimer’s disease. A community based RCT with a two-by-two factorial design |
title_sort |
effect of stimulation therapy and donepezil on cognitive function in alzheimer’s disease. a community based rct with a two-by-two factorial design |
publisher |
BMC |
publishDate |
2012 |
url |
https://doi.org/10.1186/1471-2377-12-59 https://doaj.org/article/5e9c4ca3c2354bf89d2cf7010138aace |
geographic |
Norway |
geographic_facet |
Norway |
genre |
Northern Norway |
genre_facet |
Northern Norway |
op_source |
BMC Neurology, Vol 12, Iss 1, p 59 (2012) |
op_relation |
http://www.biomedcentral.com/1471-2377/12/59 https://doaj.org/toc/1471-2377 doi:10.1186/1471-2377-12-59 1471-2377 https://doaj.org/article/5e9c4ca3c2354bf89d2cf7010138aace |
op_doi |
https://doi.org/10.1186/1471-2377-12-59 |
container_title |
BMC Neurology |
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12 |
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1 |
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1766145752366579712 |