Impact of Grape Consumption on Brain Metabolism and Neuropsychological Performance Over 1 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.

Inclusion Criteria:

- 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 Criteria:

- 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.