A Phase 1 interventional study of Grape Powder and Placebo Powder in Mild Cognitive Impairment, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2014-12-04.
Sponsored by University of California, Los Angeles · Phase 1 and Interventional
Constituents of grapes have been studied for their antioxidant, anti-inflammatory, and anticarcinogenic properties. In the past decade, there has been emerging evidence regarding a potential role for grapes in slowing cognitive decline and other effects of aging. Furthermore, evidence has been obtained in vivo that supplementation of aged rats with grape seed extract improves cognitive performance. Despite the promising accumulating data supporting the use of grapes as a safe and effective strategy for delaying the incidence of dementia, it remains unclear how grape intake would be useful with respect to factors such as dose schedule or stage of dementing illness. In general, well-controlled experimental data obtained in human subjects is in need of much further development. The investigators aim to measure effects of grape intake on cerebral metabolism and cognitive function, and to determine whether initial patterns, and magnitude of change, of cerebral metabolism assessed by positron emission tomography (PET) can serve respectively as a predictor of, and biomarker for, the magnitude of cognitive changes resulting from intake of grapes.
People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population. Numerous studies have been carried out to study the benefits of grapes associated with dementia and Alzheimer's disease (AD). In the present proposal, the investigators aim to determine 1) whether cognitive and regional cerebral metabolic changes associated with grape powder use can be identified, 2) if the presence and magnitude of therapeutic responses to grape in patients having mild cognitive decline can be predicted by particular patterns of regional brain metabolism, and 3) for any changes identified, the magnitude of those changes that correlate with the magnitude of the changes noted in the neuropsychologic parameters will be examined, which might be useful as an objective biomarker for therapeutic effect. A total of 12 patients suffering from documented decline of cognitive function (in the absence of overt dementia) will be studied. In this placebo-controlled, double-blinded study, the 12 recruited subjects who have met the screening criteria will be randomized to receive 72 g of grape powder per day or placebo. The subjects will undergo a baseline brain PET study with the radiotracer [F - 18] fluorodeoxyglucose (FDG). In addition, neuropsychological assessments will be performed at baseline and six months after initiation of therapy. Follow-up PET scans will also be obtained at six months to assess the changes in metabolism occurring with each therapy regimen.
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This study's enrollment of 12 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
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Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion Criteria:
Dietary Supplement: Grape Powder
Dietary Supplement: Placebo Powder
36 g of grape powder to be taken twice/day (total of 72 g/day) for 6 months
36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 months
Change from baseline in neuropsychological (cognitive, functional) test results
Time frame: baseline and 6 months
Change from baseline in regional cerebral metabolism
Time frame: baseline and 6 months
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles