Mild Cognitive ImpairmentPhase 2NCT03361410
Impact of Grape Consumption on Brain Metabolism and Neuropsychological Performance Over 1 Year
A Phase 2 study testing Grape Powder in people with Mild Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.
Trial 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 grapes in slowing cognitive decline and other effects of aging. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Grape Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2017to 15 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: 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
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.
Read the 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 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Grape Powder, Placebo Powder
- Keywords
- Mild Decline in Cognition, Mild Cognitive Decline, Mild Cognitive Impairment, Dementia, Positron Emission Tomography (PET), F-18 Fluorodeoxyglucose (FDG), Cerebral Metabolism, Dietary Supplement, MCI, MDC, Grape, Memory, Randomized, Non-Drug, Supplement, Non-Pharmacologic, Natural, Red Wine, Free, UCLA
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape PowderDietary supplement
36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months
Placebo PowderDietary supplement
36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Grape Powder | Experimental | Not described Receives: Dietary Supplement: Grape Powder |
| Placebo Powder | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Cerebral Metabolism
Changes from baseline in regional cerebral metabolism
Measured: Baseline and 12 months
Secondary outcomes (11)
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.
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Mini-Mental State Examination
Mini-Mental State Examination (Folstein, 1975)
Measured: 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)
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Trail Making Test Part B
Trail Making Test Part B (Reitan, 1958)
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Functional Activities Questionnaire
Functional Activities Questionnaire (Pfeffer et al., 1982)
Measured: 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.
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Non-Verbal Memory
Non-Verbal Memory (measured using the NeuroTrax BrainCare application)
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Verbal Function
Verbal Function (measured using the NeuroTrax BrainCare application)
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Stroop Interference
Stroop Interference (measured using the NeuroTrax BrainCare application)
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Problem Solving
Problem Solving (measured using the NeuroTrax BrainCare application)
Measured: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Visual Spatial Processing
Visual Spatial Processing (measured using the NeuroTrax BrainCare application)
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start18 Nov 2017
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- California Table Grape Commission
- Responsible party
- Principal investigator, Daniel H. Silverman, University of California, Los Angeles
- Investigators
- Daniel H Silverman, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361410
- Sponsor's protocol ID
- 17-001290
- Status last verified
- Feb 2023
- First submitted
- 27 Oct 2017
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03361410
- Acronym / sponsor ID
- 17-001290
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Decline in Cognition, Mild Cognitive Decline, Mild Cognitive Impairment, Dementia, Positron Emission Tomography (PET), F-18 Fluorodeoxyglucose (FDG), Cerebral Metabolism, Dietary Supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- California Table Grape Commission
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape Powder | Experimental | Dietary Supplement: Grape Powder |
| Placebo Powder | Placebo comparator | Dietary Supplement: Placebo Powder |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape Powder36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months | Dietary supplement | Grape Powder |
| Placebo Powder36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months | Dietary supplement | Placebo Powder |
Primary outcome
Regional Cerebral Metabolism
Time frame: Baseline and 12 months
Changes from baseline in regional cerebral metabolism
11 secondary outcomes
Changes in neuropsychological performance measures
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Mini-Mental State Examination
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Wechsler Adult Intelligence Scale (WAIS-III) Digit Span
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Trail Making Test Part B
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Functional Activities Questionnaire
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Verbal Memory
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Non-Verbal Memory
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Verbal Function
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Stroop Interference
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Problem Solving
Time frame: Baseline, 6 months, and 12 months
Changes in neuropsychological performance measures: Visual Spatial Processing
Time frame: Baseline, 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel H Silverman, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Grape Powder in people with Mild Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Cerebral Metabolism (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.