University Hospitals Cleveland Medical Center is participating in a Phase III clinical research study, called MINDSET, to evaluate the effectiveness of a potential new treatment option for people with mild-to-moderate Alzheimer’s disease.
The investigational drug, RVT-101, is being tested as an add-on therapy to donepezil (brand name Aricept®).
Alan Lerner, MD, Director of the Brain Health and Memory Center at UH, is the principal investigator of the study in Cleveland.
MINDSET is an international, multi-center, double blind, placebo-controlled study designed to evaluate the safety, efficacy and tolerability of RVT-101. The 24-week trial will compare RVT-101 to placebo in approximately 1,150 people with mild-to-moderate Alzheimer’s disease. All study participants will remain on donepezil therapy during the trial.
RVT-101 works by raising levels of acetylcholine, a vital chemical in the brain that helps with cognition and daily living activities. RVT-101 increases the release of acetylcholine directly, similar to turning up a faucet.
Donepezil, the most widely-used Alzheimer’s medicine, also increases acetylcholine in the brain, but does so indirectly by preventing acetylcholine from being cleared from the brain, similar to blocking a drain.
Together, RVT-101 and donepezil increase acetylcholine levels by both turning up the “faucet” and blocking the “drain.”
In an earlier 684-patient multinational Phase 2b study, RVT-101 in combination with donepezil was observed to provide statistically significant benefits in cognition and daily living activities as compared to donepezil alone. The MINDSET study is designed to confirm these results.
RVT-101 is being developed as a tablet that is taken once per day, with or without food. RVT-101 has been studied in 13 clinical trials and administered in more than 1,250 people where it was observed to be well-tolerated.
“Physicians, patients, and their families are seeking new treatments options for Alzheimer’s disease that provide clinical meaningful benefits on cognition and daily functioning. We hope the MINDSET study results in a treatment alternative for patients and their families that would make a difference in their independence and quality of life,” said Dr. Lerner, who is also a Professor of Neurology at Case Western Reserve University School of Medicine.
UH is now accepting study participants. For more information on MINDSET or to determine eligibility, visit www.AlzheimersGlobalStudy.com or call 216-464-6467.