Status:
COMPLETED
Impact of Grape Consumption on Brain Metabolism and Neuropsychological Performance Over 1 Year
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
California Table Grape Commission
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
65-85 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Referred to the UCLA NeuroPET Clinics for concern of cognitive decline and/or behavioral changes.
- Standard history, physical, and laboratory screen performed to identify possible presence of depression, substance abuse, malnourishment, medical effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation, and appropriate therapies administered (if any).
- Appropriate neurological consultation has been obtained, as well as CT/MRI and/or neurosurgical consultation if history or neurologic exam reveal findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus.
Exclusion
- Subjects under age 65 and over age 85, in order to enhance the clinical relevance of the project by focusing on the age groups in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
- Have begun cholinesterase inhibitors or memantine in the last 6 months.
- Patient lacks adequate functional status and/or caregiver support to reliably follow grape consumption regimen.
- Claustrophobia or other condition that would preclude PET from being acquired, or visual, auditory, language, or motor deficits that would preclude accurate neuropsychological testing.
- Non-English speaking subjects, due to lack of neuropsychologic testing or equivalent instruments in non-English languages.
- Subjects with a history of allergy to grapes or grape products.
Key Trial Info
Start Date :
November 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03361410
Start Date
November 18 2017
End Date
October 15 2022
Last Update
February 21 2023
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095