A Phase 2 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 to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Treatment
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Among 21 studies in Cognitive Dysfunction by University of California, Los Angeles — 3 open to participants now, 6 under way, none of them phase 3. Cognitive Dysfunction · University of California, Los Angeles.
Among the 21 studies in Cognitive Dysfunction by University of California, Los Angeles, this one is the 11th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2017, is one of 2 in phase 2, and was the 12th registered.
3,875 studies on the registry are indexed under Cognitive Dysfunction; 1,121 are open to participants now.
Browse Cognitive Dysfunction studies →3 of the 21 studies in Cognitive Dysfunction by University of California, Los Angeles are open now, in 1 country. Recruiting first, the newest first:
University of California, Los Angeles · Sites in United States
Ages 65+
University of California, Los Angeles · Sites in United States
Ages 50+ · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 45–70
By country, each count listing its studies:
Of the 751 Cognitive Dysfunction studies recruiting now, 363 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 3 · Phase 3 2 · Phase 4 2
First in 2000; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 64 across 2,796 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 58 across the 18 interventional studies, 30 across the 2 observational. Of the 13 that completed or were terminated, 7 (54%) have results posted.
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University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
1 of the studies in Cognitive Dysfunction by University of California, Los Angeles that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04558164University of California, Los AngelesNetwork-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment | 2026-11-30 |
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Among the 21 studies in Cognitive Dysfunction by University of California, Los Angeles, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 12 months
36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months
Regional Cerebral Metabolism
Changes from baseline in regional cerebral metabolism
Time frame: Baseline and 12 months
Changes in neuropsychological performance measures
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
Changes in neuropsychological performance measures: Mini-Mental State Examination
Mini-Mental State Examination (Folstein, 1975)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Wechsler Adult Intelligence Scale (WAIS-III) Digit Span
Wechsler Adult Intelligence Scale (WAIS-III) Digit Span (Wechsler, 1997)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Trail Making Test Part B
Trail Making Test Part B (Reitan, 1958)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Functional Activities Questionnaire
Functional Activities Questionnaire (Pfeffer et al., 1982)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Verbal Memory
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
Changes in neuropsychological performance measures: Non-Verbal Memory
Non-Verbal Memory (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Verbal Function
Verbal Function (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Stroop Interference
Stroop Interference (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Problem Solving
Problem Solving (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Visual Spatial Processing
Visual Spatial Processing (measured using the NeuroTrax BrainCare application)
Time frame: Baseline, 6 months, and 12 months
Ran from Nov 2017 to primary completion in Oct 2022, 58 months.
Of 145 non-industry phase 2 interventional studies under Cognitive Dysfunction, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 64. This study's 58 months is close to that.
Counting every sponsor, half of 186 studies reached it within 42 months; a quarter within 22 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Grape
University of California, Los Angeles →