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By Dr. Laszlo Mate
The MINDSET study is a phase 3 clinical research study evaluating a new investigational treatment for mild-to-moderate Alzheimer’s disease.
This study drug, known as RVT-101, is being studied as an add-on therapy to donepezil (sometimes known as Aricept®), the most widely used medicine to treat Alzheimer’s disease today. In a previous 684-patient clinical study, the combination of RVT-101 and donepezil provided patients with statistically significant benefits in cognition and ability to perform daily living activities, as compared to donepezil alone.
The MINDSET study is designed to confirm these results and could be the final study required for the FDA approval of RVT-101.
The study involves approximately 170 expert physicians at clinics around the world, referred to as research “investigators.” I am pleased to be one of these investigators, and will be seeing patients for the study at my clinic right here in Palm Beach.
About RVT-101, A Potential
Treatment For Mild-To-Moderate Alzheimer’s Disease
RVT-101 works by raising levels of acetylcholine, a vital chemical in the brain that is believed to help with cognition and performing daily living activities. RVT-101 works by raising levels of acetylcholine directly, similar to turning up a faucet. Donepezil also increases acetylcholine, but does so indirectly by preventing acetylcholine from being cleared from the brain, similar to blocking a drain. In combination, RVT-101 and donepezil work together to increase acetylcholine by both turning up the faucet and blocking the drain.
RVT-101 only increases acetylcholine in the brain (not the rest of the body), so researchers believe drug the drug avoids some of the unwanted side effects associated with donepezil. RVT-101 has already been studied in 13 clinical trials and administered in over 1,250 individuals, and showed a favorable safety and tolerability profile in those studies.
RVT-101 is administered as a once-daily, oral therapy without the need for PET imaging, MRI monitoring or IV infusions.
What Is Involved in Study Participation
The MINDSET program will consist of a 6-month double-blind study, in which patients will have a 50-50 chance of receiving RVT-101 or placebo.“Double-blind” means that neither the patient nor the investigator knows whether the patient is receiving RVT-101 or placebo.
All patients who complete the double-blind study will be eligible to enroll in a 12-month open-label extension study in which all patients will receive RVT-101.
Study participants will receive thestudy medication, study-related medical care, and study-provided donepezil at no cost to them. Transportation to and from study visits can be provided or reimbursed. Compensation for study-related time may also be available. Insurance is not required to participate.
Who Is Eligible
Individuals between the ages of 50 and 85 who are suffering from Alzhemier’s disease or memory loss and taking the medication donepezil (often known as Aricept®) may be eligible to participate.
If you or a loved one might be interested in participating in the MINDSET study, please call the practice of Dr. Laszlo Mate at 561-626-5551
Editor’s Note: Dr. Laszlo Mate, a neurologist in Palm Beach who specializes in the treatment of Alzheimer’s disease and dementia, recently began enrolling patients in a clinical study evaluating a potential new treatment for mild-to-moderate Alzheimer’s disease. We invited Dr. Mate to share more information about this study, called MINDSET. If you or a loved one might be interested in participating, please call Dr. Mate’s office at 561-626-5551.