Rosiglitazone Monotherapy in Mild-to-Moderate Alzheimer’s Disease: Results from a Randomized, Double-Blind, Placebo-Controlled Phase III Study
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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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Phase III clinical trials using rosiglitazone failed to show efficacy for the treatment of AD.
“However, phase III clinical trials, using rosiglitazone, failed to show efficacy for the treatment of AD (Gold et al., 2010).”
From Mechanisms Underlying the Rapid Peroxisome Proliferator-Activated Receptor-γ-Mediated Amyloid Clearance and Reversal of Cognitive Deficits in a Murine Model of Alzheimer's Disease (2012) · cites this paper as Gold et al., 2010
The Introduction describes one phase III rosiglitazone trial in people with mild-to-moderate AD, and the Conclusion reports no evidence of efficacy. The cited paper supports that result for its trial, but not the claim that multiple phase III trials failed to show efficacy. (LLM, conf=0.86)
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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)
- 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
- 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
- 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
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology › 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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