Cited by 361Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchCholinesterase and Neurodegenerative Diseases

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Rosiglitazone Monotherapy in Mild-to-Moderate Alzheimer’s Disease: Results from a Randomized, Double-Blind, Placebo-Controlled Phase III Study

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Gold, Michael, Alderton, Claire, Zvartau-Hind, Marina, Egginton, Sally, Saunders, Ann M., Irizarry, Michael, Craft, Suzanne, Landreth, Gary, Linnamägi, Ülla, Sawchak, Sharon·2010·Dementia and Geriatric Cognitive Disorders

DOI 10.1159/000318845PMC PMC3214882

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Abstract

Background/Aims: A 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. Methods: This 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+). Results: At 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%). Conclusion: No 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.

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Authors: Gold, M., Alderton, C., Zvartau-Hind, M., Egginton, S., Saunders, A. M., Irizarry, M., Craft, S., Landreth, G., Linnamägi, Ü., & Sawchak, S.
Affiliations: GlaxoSmithKline (United Kingdom) (GB)
Duke University (US)
University of Washington (US)
Case Comprehensive Cancer Center (US)
University of Tartu (EE)
ORCID: Alderton, Claire
Saunders, Ann M.
Irizarry, Michael
Craft, Suzanne
Landreth, Gary
Venue: Dementia and Geriatric Cognitive Disorders
Publisher: S. Karger AG
Published: 2010
Volume: 30
Issue: 2
Pages: 131-146
ISSN: 1420-8008 (ISSN-L)
1421-9824
DOI: 10.1159/000318845
PMC: PMC3214882
OpenAlex: W1978999542
Cited by: 361
References: 56
Citations by year: 2026: 12 · 2025: 17 · 2024: 20 · 2023: 21 · 2022: 23 · 2021: 25 · 2020: 26 · 2019: 22 · 2018: 22 · 2017: 19 · 2016: 22 · 2015: 24 · 2014: 24 · 2013: 25 · 2012: 31
FWCI: 18.20
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.karger.com/Services/SiteLicenses (vor)
www.karger.com/Services/SiteLicenses (tdm)
Locations: Dementia and Geriatric Cognitive Disorders (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: GlaxoSmithKline
National Institute on Aging (R01AG030482)
National Institute of Neurological Disorders and Stroke
Topics: Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
Keywords: Alzheimer's disease, peroxisome proliferator-activated receptor gamma agonists, APOE ε4 genotype, donepezil, cognitive function, global function, peripheral edema, drug safety and tolerability, ADAS-Cog
MeSH terms: Rosiglitazone, Donepezil, Aged, Aged, 80 and over, Alleles, Alzheimer Disease, Apolipoproteins E, Cholinesterase Inhibitors, Edema, Female, Genotype, Humans, Hypoglycemic Agents, Indans, Intelligence Tests, Interview, Psychological, Male, Middle Aged, Nasopharyngitis, Piperidines, Treatment Outcome, Thiazolidinediones, PPAR gamma, Drug-Related Side Effects and Adverse Reactions

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Rosiglitazone Monotherapy in Mild-to-Moderate Alzheimer’s Disease: Results from a Randomized, Double-Blind, Placebo-Controlled Phase III Study

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