Evidence map›Paper›PMID 22813231›Full record

Trial reportBMC neurology2012

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.

Fred Andersen, Matti Viitanen, Dag S Halvorsen, Bjørn Straume, Tom Wilsgaard, Torgeir A Engstad

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00443014 (Phase 4 Study of Cognitive Therapy and Donepezil in Alzheimers Disease.), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00443014 phase4completednot on this map

Phase 4 Study of Cognitive Therapy and Donepezil in Alzheimers Disease.

TypeinterventionalSponsorUniversity Hospital of North NorwayRan2003 to 2009Enrolled187ConditionsAlzheimer DiseaseArmsCognitive, physical and social stimulation
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 3 countries.

Fred AndersenDepartment of Community Medicine, University of Tromsø, Norway. frea@online.no
Matti Viitanen
Dag S Halvorsen
Bjørn Straume
Tom Wilsgaard
Torgeir A Engstad
UiT The Arctic University of Norway · NOUniversity Hospital of North Norway · NOUniversity of Turku · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgressive 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

designA 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.

settingNine rural municipalities in Northern Norway.

participants187 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.

interventionsIn 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.

resultsMMSE 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.

conclusionIn 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 registrationClinicalTrials.gov (Identifier: NCT00443014). EudraCT database (no 2004-002613-37).

Indexed as

AgedAged, 80 and overAlzheimer DiseaseCholinesterase InhibitorsCognition DisordersCombined Modality TherapyComorbidityDonepezilDouble-Blind MethodFemaleHumansIndansMaleNorwayPhysical Therapy ModalitiesPiperidinesCholinesterase InhibitorsDonepezilIndansPiperidines

Identifiers

PMID22813231
PMCPMC3481364
OpenAlexW2148074852

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.