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BDPP Treatment for Mild Cognitive Impairment and Prediabetes

Recruiting

People with mild cognitive impairment (MCI) are at risk of developing dementia. Those with deficits in short-term recall (amnestic MCI) are at significant risk of developing Alzheimer's disease. In this study, people with MCI and prediabetes will consume a nutraceutical drink, called a Bioactive Dietary Polyphenol Preparation (BDPP), to see if it can improve cognition and delay or prevent dementia.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years All No
June 2015
June 2021
48

  • Amnestic MCI
  • Impaired fasting glucose, defined by American Diabetes Association criteria (fasting blood sugar between 100 and 125 mg/dl) or clinically stable type 2 diabetes
  • Knowledgeable partner who spends at least 5 hours/week with the participant and can provide information about the participant's psychosocial functioning

  • Unstable medically or neurologically to safely enroll in trial
  • Type 1 diabetes mellitus
  • Diagnosis of dementia due to Alzheimer's disease

There is increasing evidence that risk factors for metabolic syndrome such as prediabetes increase risk of developing cognitive impairment and possibly Alzheimer's. People with MCI and prediabetes may be at particular risk due to insulin resistance in the brain. A possible target is a drug targeting insulin resistance with good blood-brain-barrier penetrance.

In this Phase I study, participants will consume a Bioactive Dietary Polyphenol Preparation (BDPP), a combination of three nutraceutical preparations: grape seed polyphenolic extract, resveratrol, and Concord grape juice. This drink contains abundant concentrations of polyphenols, naturally occurring and synthetic chemicals characterized by the presence of many phenol structural units. BDPP administration has been associated with improved cognition and brain plasticity in mouse models of metabolic syndrome and Alzheimer's. Investigators seek to demonstrate the safety and penetration of oral BDPP in humans to assess its potential as a treatment for MCI and prediabetes.

Name City State Zip Status Primary Contact
Johns Hopkins University
Baltimore Maryland 21224 Recruiting Sarah Lawrence, MS
410-550-9020

Johns Hopkins University

  • Icahn School of Medicine at Mount Sinai

Name Phone Email
Sarah Lawrence 410-550-9020 swoody1@jhmi.edu
Toni White, BA 410-550-6486 twhite46@jhmi.edu

NCT02502253

BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes