Over two-dozen academic institutions will hire volunteers in the upcoming months for a national, phase II clinical trial to inspect the effects of resveratrol on persons with mild to moderate dementia owing to Alzheimer's disease.
Resveratrol is a compound found in red grapes, red grape juice, red wine, chocolate, tomatoes and peanuts.
Pre-clinical and pilot clinical research studies suggest that resveratrol may prevent diabetes, act as a natural cancer fighter, ward off cardiovascular disease, and prevent memory loss, but there has been no large definitive study of its effects in humans.
The risk of all of these diseases increases with aging. Animal studies suggest that resveratrol may impede molecular mechanisms of aging. Human population studies suggest several health benefits from modest daily consumption of red wine, but the mechanisms of action in the body are unknown.
R. Scott Turner, M.D., Ph.D., director of Georgetown University Medical Center's Memory Disorders Program, is the lead investigator for the national study.
"Most resveratrol studies showing any health benefits have been conducted in animal models, such as mice, and with doses that far exceed intake from sipping wine or nibbling on chocolate," said Turner.
"With this clinical trial, we'll find out if daily doses of pure resveratrol can delay or alter memory deterioration and daily functioning in people with mild to moderate dementia due to Alzheimer's.
"During this study, we will also test whether resveratrol improves glucose and insulin metabolism in older individuals-although those who already have diabetes will not be included in this study," he stated.
Resveratrol is not approved by the Food and Drug Administration for the treatment of Alzheimer's. It is not known if resveratrol can change the course of the disease.
Not everyone who enrolls in the study will receive resveratrol. Half of the participants will receive a placebo (a sugar pill made to look like the resveratrol pill) to allow researchers to more objectively test the benefits of resveratrol. Neither the patient nor the clinical staff will know if the study participant is receiving the placebo or resveratrol until the end of the study.
"This is the gold-standard for conducting a clinical study because it allows us to objectively determine if resveratrol is offering any benefits," explained Brigid Reynolds, NP, lead investigator for the study at Georgetown.
In addition, the phase II study will examine the safety and tolerability of resveratrol administered twice daily with a dose increase planned at three-month intervals, she noted.
The resveratrol study will be conducted at 26 U.S. academic institutions that are affiliated with the Alzheimer's Disease Cooperative Study.
The research is sponsored by the Alzheimer's Disease Cooperative Study (ADCS), through a grant from the National Institute on Aging (NIA).