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


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


Dementia And Geriatric Cognitive Disorders, Volume: 30, No.: 2, Pages.: 131-146

Year of Publication



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.; Copyright © 2010 S. Karger AG, Basel.

Bibtex Citation

@article{Gold_2010, doi = {10.1159/000318845}, url = {}, year = 2010, publisher = {S. Karger {AG}}, volume = {30}, number = {2}, pages = {131--146}, author = {Michael Gold and Claire Alderton and Marina Zvartau-Hind and Sally Egginton and Ann M. Saunders and Michael Irizarry and Suzanne Craft and Gary Landreth and Ülla Linnamägi and Sharon Sawchak}, title = {Rosiglitazone Monotherapy in Mild-to-Moderate Alzheimer's Disease: Results from a Randomized, Double-Blind, Placebo-Controlled Phase {III} Study}, journal = {Dementia and Geriatric Cognitive Disorders} }


administration & dosage, adverse, adverse effects, aged, aged, 80 and over, agonists, alleles, alzheimer disease, apolipoproteins e, chemically induced, cholinesterase inhibitors, drug therapy, drugrelated side effects and adverse reactions, edema, events, extended, female, genetics, genotype, humans, hypoglycemic agents, indans, intelligence tests, interview psychological, male, metabolism, middle aged, nasopharyngitis, physiopathology, piperidines, ppar gamma, release, rosiglitazone, rsg, thiazolidinediones, treatment outcome, xr

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions