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This Phase 1b clinical trial will examine the safety and tolerability of a combination treatment using three grape-derived compounds in people with very early stages of Alzheimer’s disease.
Giulio Maria Pasinetti, M.D., Ph.D.
Icahn School of Medicine at Mount Sinai
New York, NY - United States
Background
Mild cognitive impairment (MCI) is a condition in which an individual may have some memory decline but not enough to affect his or her ability to perform daily functions independently. Some but not all people who have MCI progress to Alzheimer’s disease. Diabetes and prediabetes (a condition in which blood sugar levels are higher than normal, but not considered to be diabetic) have been shown to increase risk for cognitive decline and the development of Alzheimer’s disease.
Research Plan
Giulio Maria Pasinetti, M.D., Ph.D., and colleagues will investigate the use of a dietary supplement called “Biologically Active Dietary Polyphenol Preparation” (BDPP) to help slow or prevent the development of Alzheimer’s in people with MCI and prediabetes. BDPP contains a mixture of polyphenols, a class of chemicals found in certain plants (e.g. grapes) that may support brain health. One example of a polyphenol is resveratrol, which is found in red wine and grape juice and is being studied for its potentially beneficial effects on the normal and diseased brain.
Impact
Dr. Pasinetti and colleagues will assess the safety, side effects and optimal dosing of BDPP and determine if BDPP can enter the brain. The researchers will measure the levels of BDPP as well as certain molecules linked to the progression of Alzheimer’s in cerebrospinal fluid (the fluid that surrounds the brain and spinal cord). They will also examine if BDPP treatment helps improve brain function. This study could pave the way for more extensive tests of BDPP as a way to slow, stop, or prevent the development of Alzheimer’s disease.
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