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Date Contacts Phone Aug 10, 2016 News Release George Stamatis Department of Marketing and Communications 11100 Euclid Avenue Cleveland, OH 44106 216.844.3667 Phase 3 Alzheimer’s Disease Clinical Trial for Potential Add-on Therapy to Donepezil (Aricept) Now Enrolling at University Hospitals MINDSET will seek to confirm results of a prior research study in which the investigational drug, RVT-101, demonstrated statistically significant improvements in cognition and daily living activities in people with mild-to-moderate Alzheimer's disease CLEVELAND — University Hospitals Case 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 RVT101 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. RVT101 has been studied in 13 clinical trials and administered in more than 1,250 people where it was observed to be well-tolerated. “We are very excited to participate in the MINDSET study with RVT-101,” said Dr. Lerner, who is also a Professor of Neurology at Case Western Reserve University School of Medicine. “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.” UH is now accepting study participants. For more information on MINDSET or to determine eligibility, visit www.AlzheimersGlobalStudy.com or call 216-464-6467. ### About University Hospitals Founded in May 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 40 outpatient health centers and primary care physician offices in 15 counties throughout Northeast Ohio. At the core of our $4 billion health system is University Hospitals Case Medical Center, ranked among America’s best hospitals by U.S. News & World Report. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and genetics. Its main campus includes UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. UH is the second largest employer in Northeast Ohio with 26,000 employees. For more information, go to www.UHhospitals.org.
