Evidence map›Paper›PMID 21795660›Full record

Trial reportNeurology2011

A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease.

M Sano, K L Bell, D Galasko, J E Galvin, R G Thomas, C H van Dyck, P S Aisen

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 165 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
165citing papers in PubMed, 15 pooled it
24.8field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

165 citing papers in PubMed, 15 syntheses or guidelines pooled it, 322 citations in OpenAlex.

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  4. Effects of saffron (Crocus sativus L.) on cognitive function. A systematic review of RCTs.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
    Pooled it
  5. The efficacy of statins in the treatment of Alzheimer's disease: a meta-analysis of randomized controlled trial.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
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  8. Guideline
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  14. Impact on cognitive function-are all statins the same?Current atherosclerosis reports · 2015
    Pooled it
  15. Statins for the treatment of dementia.The Cochrane database of systematic reviews · 2014
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105 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

M SanoMount Sinai School of Medicine, Bronx, NY 10468, USA. mary.sano@mssm.edu
K L Bell
D Galasko
J E Galvin
R G Thomas
C H van Dyck
P S Aisen
Yale University · USUniversity of California, San Diego · USNYU Langone Health · US

Funding

TRIAL OF VALPROATE TO ATTENUATE THE PROGRESSION OF ADU01AG010483 · NIA · UNIVERSITY OF ROCHESTER · PI AISEN, PAUL S. · 1991 to 2012
$116.2M
RECRUITMENT COREU19AG010483 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FELDMAN, HOWARD · 2013 to 2020
$80.6M
PSYCHOSOCIAL COREP30AG008051 · NIA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI SHAO, YONGZHAO · 1990 to 2019
$36.1M
NIA NIH HHS P30 AG008051NIA NIH HHS U01AG10483NIA NIH HHS U19 AG010483
6 · The paper itself

Abstract

backgroundLowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD.

objectiveTo determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD.

methodsThis randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were randomly assigned to receive simvastatin, 20 mg/day, for 6 weeks then 40 mg per day for the remainder of 18 months or identical placebo. The primary outcome was the rate of change in the Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-Cog). Secondary outcomes measured clinical global change, cognition, function, and behavior.

resultsA total of 406 individuals were randomized: 204 to simvastatin and 202 to placebo. Simvastatin lowered lipid levels but had no effect on change in ADAS-Cog score or the secondary outcome measures. There was no evidence of increased adverse events with simvastatin treatment.

conclusionSimvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that simvastatin 40 mg/day does not slow decline on the ADAS-Cog.

Indexed as

AgedAlzheimer DiseaseApolipoproteins ECholesterolCholesterol, LDLCholinesterase InhibitorsCognitionDisease ProgressionDouble-Blind MethodFemaleFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLipidsLiver Function TestsMaleApolipoproteins ECholesterolCholesterol, LDLCholinesterase InhibitorsHydroxymethylglutaryl-CoA Reductase InhibitorsLipidsNootropic AgentsSimvastatin

Identifiers

PMID21795660
PMCPMC3149154
OpenAlexW2147048440

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.