University of California, Los Angeles
Los Angeles, California, 90095, United States
NCT Number: NCT03361410
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 with grape seed extract in aged rats improves cognitive performance, and that supplementation with grapes in people having decline in cognition leads to preservation of metabolism in brain regions important to cognitive function over a period of six months. The investigator aims to measure effects of grape intake on cerebral metabolism and neuropsychological performance, 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 over a period of at least one year.
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Notify Me65 year–85 year
All sexes
Interventional
Phase 2
Los Angeles, California, 90095, United States
As the number of people age 65 years old or older continues to increase, population aging has a profound impact on healthcare systems, and specifically the emergence of dementia in literally epidemic proportions. Numerous studies on the associations between grape consumption and dementia and Alzheimer's disease have found evidence to support the use of grapes and grape products as a safe and effective way to treat and delay the onset of dementia. For the present study, the Investigator aims (1) to identify regional cerebral metabolic changes associated with grape intake, (2) to determine whether the presence and magnitude of therapeutic responses to grape in patients undergoing neuroimaging evaluation for cognitive decline can be predicted by particular patterns of regional brain metabolism, and (3) to statistically assess the relationships between brain metabolism assessed by PET and cognitive function in randomized experimental arms. A total of 32 patients from a community sample of patients referred to UCLA NeuroPET Clinics by their neurologists for further evaluation by brain imaging will be studied in this placebo-controlled, double-blinded study. Subjects who have met the screening criteria will be randomized to receive 72 g of grape powder or placebo, reconstituted in water, per day. Regional brain metabolism will be measured with a PET scanner, and cognitive function will be measured by a neuropsychologic test battery assessed at baseline, 6 months following initiation of consumption, and 1 year following initiation of consumption of the grapes of placebo formulation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months
36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months
Time frame: Baseline and 12 months
Changes from baseline in regional cerebral metabolism
Time frame: Baseline, 6 months, and 12 months
Changes in cognitive performance over time within each group will be measured through the neuropsychological assessments listed below, as administered by trained psychometrists under direct supervision of a licensed neuropsychologist, and will be correlated with changes in regional cerebral metabolism.
Time frame: Baseline, 6 months, and 12 months
Mini-Mental State Examination (Folstein, 1975)
Time frame: Baseline, 6 months, and 12 months
Wechsler Adult Intelligence Scale (WAIS-III) Digit Span (Wechsler, 1997)
Time frame: Baseline, 6 months, and 12 months
Trail Making Test Part B (Reitan, 1958)
Time frame: Baseline, 6 months, and 12 months
Functional Activities Questionnaire (Pfeffer et al., 1982)
Time frame: Baseline, 6 months, and 12 months
NeuroTrax BrainCare, a cloud-based computer application that includes a series of tests and associated reports, will be used to measure Verbal Memory.
Time frame: Baseline, 6 months, and 12 months
Non-Verbal Memory (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Verbal Function (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Stroop Interference (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Problem Solving (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Visual Spatial Processing (measured using the NeuroTrax BrainCare application)
University of California, Los Angeles
Other
Examining the Impact of Grape Consumption on Brain Metabolism and Neuropsychological Performance in Patients Undergoing Neuroimaging Evaluation for Cognitive Decline: A Double-blinded Placebo Controlled Expansion Study
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