What is it and what does it include?
This phase III interventional treatment study, also known as REFLECT-3, evaluated the relationship between APOE ε4 allele status and the effectiveness of 48 weeks of double-blind treatment with RSG XR versus placebo on cognitive function and overall clinical response in subjects who are maintained on a stable dose of an approved acetylcholinesterase inhibitor (AChEI; i.e., rivastigmine, galantamine, or donepezil).
The study took place between 12 July 2006 to 02 March 2009, lasted 54 weeks and included 1468 participants over the age of 50. A total of 176 centers screened and enrolled at least one subject in the following countries: United Kingdom (UK), Canada, Poland, France, Spain, South Africa, Netherlands, Sweden, Czech Republic, Slovenia, Germany, Finland, Slovakia, Belgium, Bulgaria, Australia, Malaysia, Philippines, Korea, Hong Kong, Singapore, and the United States (US).
How can I use this dataset to advance my research?
This dataset is ideal if:
- you’re studying the effects of donepezil, rivastigmine, or galantamine and/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