Evidence map›Paper›PMID 20733306›Full record

Trial reportDementia and geriatric cognitive disorders2010

Rosiglitazone monotherapy in mild-to-moderate Alzheimer's disease: results from a randomized, double-blind, placebo-controlled phase III study.

Michael Gold, Claire Alderton, Marina Zvartau-Hind, Sally Egginton, Ann M Saunders, Michael Irizarry, Suzanne Craft, Gary Landreth, Ulla Linnamägi, Sharon Sawchak

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Dementia and geriatric cognitive disorders, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 176 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
176citing papers in PubMed, 10 pooled it
11.4field-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.

NCT02409238 phase4terminatedstarted 2015, after this paper: background citation

Insulin Resistance and Mild Cognitive Impairment (MCI) in Older Chinese Adults With Pre-Diabetes and Diabetes: Cognitive Effects of Lifestyle Intervention and Metformin Treatment in a Randomized Controlled Trial

Ran2015Enrolled105Registered outcomes16Posted comparisons0ConditionsDiabetes Mellitus, Type 2, Insulin Resistance, Mild Cognitive ImpairmentArmsIntensive Lifestyle Intervention, Metformin, Standard LIfestyle Recommendation
PMID 20452916PMID 24577463PMID 24357209PMID 21592048PMID 25537705PMID 25537706PMID 16286438PMID 16446752PMID 18602098PMID 20435794other papers from this trial
Open the trial in the graph
NCT00428090 phase3completednot on this map

A 24-week, Double-blind, Double-dummy, Randomized, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets), Donepezil, and Placebo as Monotherapy on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease. (REFLECT-1)

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2008Enrolled862ConditionsAlzheimer's DiseaseArmsRosiglitazone
NCT00550420 phase3terminatednot on this map

An Open-label Extension to Study AVA105640, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2009Enrolled331ConditionsAlzheimer's DiseaseArmsRosiglitazone XR
3 · Its place in the literature

Who cites it

176 citing papers in PubMed, 10 syntheses or guidelines pooled it, 349 citations in OpenAlex.

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  8. Drug repositioning for Alzheimer's disease.Nature reviews. Drug discovery · 2012
    Pooled it
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  11. Effects of the SGLT2 inhibitor dapagliflozin in early Alzheimer's disease: A randomized controlled trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Trial
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  16. Neuroinflammation and Tauopathies.Molecular biology reports · 2026
    Review
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116 more citing papers are in PubMed but not listed here.

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

10 authors at 6 institutions in 4 countries.

Michael GoldNeurosciences Medicines Development Center, GlaxoSmithKline, Stockley Park, Harlow, UK. michael.2.gold@gsk.com
Claire Alderton
Marina Zvartau-Hind
Sally Egginton
Ann M Saunders
Michael Irizarry
Suzanne Craft
Gary Landreth
Ulla Linnamägi
Sharon Sawchak
GlaxoSmithKline (Netherlands) · NLCase Comprehensive Cancer CenterDuke University · USGlaxoSmithKline (United Kingdom) · GBUniversity of Tartu · EEUniversity of Washington · US

Funding

NIA NIH HHS R01 AG030482
6 · The paper itself

Abstract

BACKGROUND/

aimsA phase II study of the peroxisome proliferator-activated receptor-γ agonist rosiglitazone extended release (RSG XR) in mild-to-moderate Alzheimer's disease (AD) detected a treatment benefit to cognition in apolipoprotein E(APOE)-ε4-negative subjects. The current phase III study with prospective stratification by APOE genotype was conducted to confirm the efficacy and safety of RSG XR in mild-to-moderate AD. An open-label extension study assessed the long-term safety and tolerability of 8 mg RSG XR.

methodsThis double-blind, randomized, placebo-controlled study enrolled 693 subjects. Within 2 APOE allelic strata (ε4-positive, ε4-negative), subjects were randomized (2:2:2:1) to once-daily placebo, 2 mg RSG XR, 8 mg RSG XR or 10 mg donepezil (control). Coprimary endpoints were change from baseline to week 24 in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score, and week 24 Clinician's Interview-Based Impression of Change plus caregiver input (CIBIC+).

resultsAt week 24, no significant differences from placebo in change from baseline in coprimary endpoints were detected with either the RSG XR dose in APOE-ε4-negative subjects or overall. For donepezil, no significant treatment difference was detected in ADAS-Cog; however, a significant difference was detected (p = 0.009) on the CIBIC+. Peripheral edema was the most common adverse event for 8 mg RSG XR (15%) and placebo (5%), and nasopharyngitis for 2 mg RSG XR (7%).

conclusionNo evidence of efficacy of 2 mg or 8 mg RSG XR monotherapy in cognition or global function was detected in the APOE-ε4-negative or other analysis populations. The safety and tolerability of RSG XR was consistent with its known pharmacology.

Indexed as

Alzheimer DiseaseThiazolidinedionesAgedAged, 80 and overAllelesApolipoproteins ECholinesterase InhibitorsDonepezilDrug-Related Side Effects and Adverse ReactionsEdemaFemaleGenotypeHumansHypoglycemic AgentsIndansIntelligence TestsApolipoproteins ECholinesterase InhibitorsDonepezilHypoglycemic AgentsIndansPiperidinesPPAR gammaRosiglitazoneThiazolidinediones

Identifiers

PMID20733306
PMCPMC3214882
OpenAlexW1978999542

What Socratic holds

Textmetadata
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 Socratic graph.