ADDI's Editorial Take

What is it and what does it include? 

This Phase III open-label study investigated the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD and who previously completed 12 months of treatment in study 49653/461 (Brain Imaging Study Of Rosiglitazone Efficacy And Safety In Alzheimer's Disease). Overall subject participation lasted approximately 50 weeks, and the study was conducted at seven centers in two countries including one site in Canada, and six in the United States. A total of 33 subjects ages 50 and older participated in this study. 

How can I use this dataset to advance my research? 

This dataset is ideal if: 

  • you’re studying the effects of donepezil or Rosiglitazone (Avandia) versus placebo on cerebral glucose metabolism or cognitive performance on patients with positive and negative APOE ε4 status. 
  • you’re investigating the relevance of the APOE ε4 allele in AD pathogenesis. 
  • you’re examining the time course of any cognitive effects of RSG XR. 
  • you’re performing exploratory post-hoc evaluation of any association between effects of RSG XR on cognitive measures and glycemia (as measured by glycosylated hemoglobin [HbA1c]) and on other exploratory surrogate markers. 
  • you’re investigating the effects of RSG XR on short-term memory. 
  • you’re investigating the effects of RSG XR on subject- and caregiver-reported health outcomes measures, including resource utilization, subject quality of life (QoL), and caregiver QoL. 

Has this dataset helped researchers understand Alzheimer’s and other dementias better? 

Of course!  

  • AD & Pharmacokinetics: 

In 2011, researchers found no evidence of statistically or clinically significant efficacy in cognition or global function for RSG XR as adjunctive therapy to ongoing AChEIs, as well as no evidence of an interaction between treatment and APOE status. However, researchers point at further investigation needed to determine whether RSG fails to accumulate to effective levels in target tissues in the brain, particularly in subjects with more advanced AD, and they don’t rule out that a PPAR with high penetration of the blood brain barrier may provide a therapeutic option in treatment of AD. 2011 – DOI:  10.2174/156720511796391935