Mild Cognitive ImpairmentPhase 1NCT01573611
Impact of Grape Consumption on Brain Metabolism and Cognitive Function
A Phase 1 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 years and older
- 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Nov 2014
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Cognitive deficit and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline which the patient's physician deems to be reliable.
- If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
- Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
- Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.
Who cannot join
- Subjects under age 65 will not be recruited, 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.
- Already diagnosed with Alzheimer's disease or other cause of dementia
- Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
- Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.)
- Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
- Currently receiving medication used specifically to treat Alzheimer's disease or other dementia-related disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Medical Center
Los Angeles, California, 90095-6942
About this study
Official title: Examining the Impact of Grape Consumption on Brain Metabolism and Cognitive Function in Patients With Mild Cognitive Impairment
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 of aged rats with grape seed extract improves cognitive performance. Despite the promising accumulating data supporting the use of grapes as a safe and effective strategy for delaying the incidence of dementia, it remains unclear how grape intake would be useful with respect to factors such as dose schedule or stage of dementing illness. In general, well-controlled experimental data obtained in human subjects is in need of much further development. The investigators aim to measure effects of grape intake on cerebral metabolism and cognitive function, 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.
Read the detailed description
People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population. Numerous studies have been carried out to study the benefits of grapes associated with dementia and Alzheimer's disease (AD). In the present proposal, the investigators aim to determine 1) whether cognitive and regional cerebral metabolic changes associated with grape powder use can be identified, 2) if the presence and magnitude of therapeutic responses to grape in patients having mild cognitive decline can be predicted by particular patterns of regional brain metabolism, and 3) for any changes identified, the magnitude of those changes that correlate with the magnitude of the changes noted in the neuropsychologic parameters will be examined, which might be useful as an objective biomarker for therapeutic effect. A total of 12 patients suffering from documented decline of cognitive function (in the absence of overt dementia) will be studied. In this placebo-controlled, double-blinded study, the 12 recruited subjects who have met the screening criteria will be randomized to receive 72 g of grape powder per day or placebo. The subjects will undergo a baseline brain PET study with the radiotracer [F - 18] fluorodeoxyglucose (FDG). In addition, neuropsychological assessments will be performed at baseline and six months after initiation of therapy. Follow-up PET scans will also be obtained at six months to assess the changes in metabolism occurring with each therapy regimen.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Grape Powder, Placebo Powder
- Keywords
- mild cognitive impairment, dementia, positron emission tomography (PET), F-18 Fluorodeoxyglucose (FDG), cerebral metabolism, dietary supplement
- Medical subject headings
- Cognitive Dysfunction, Dementia
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 6 months
Placebo PowderDietary supplement
36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 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.
Change from baseline in neuropsychological (cognitive, functional) test results
Measured: baseline and 6 months
Change from baseline in regional cerebral metabolism
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionNov 2014
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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel H. Silverman, University of California, Los Angeles
- Investigators
- Daniel H. Silverman, MD, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573611
- Sponsor's protocol ID
- 11002966
- Status last verified
- Dec 2014
- First submitted
- 5 Apr 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. 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 Cognitive Function in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01573611
- Acronym / sponsor ID
- 11002966
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, dementia, positron emission tomography (PET), F-18 Fluorodeoxyglucose (FDG), cerebral metabolism, dietary supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Apr 2012 (estimated)
- 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 of aged rats with grape seed extract improves cognitive performance. Despite the promising accumulating data supporting the use of grapes as a safe and effective strategy for delaying the incidence of dementia, it remains unclear how grape intake would be useful with respect to factors such as dose schedule or stage of dementing illness. In general, well-controlled experimental data obtained in human subjects is in need of much further development. The investigators aim to measure effects of grape intake on cerebral metabolism and cognitive function, 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.
Detailed description
People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population. Numerous studies have been carried out to study the benefits of grapes associated with dementia and Alzheimer's disease (AD). In the present proposal, the investigators aim to determine 1) whether cognitive and regional cerebral metabolic changes associated with grape powder use can be identified, 2) if the presence and magnitude of therapeutic responses to grape in patients having mild cognitive decline can be predicted by particular patterns of regional brain metabolism, and 3) for any changes identified, the magnitude of those changes that correlate with the magnitude of the changes noted in the neuropsychologic parameters will be examined, which might be useful as an objective biomarker for therapeutic effect. A total of 12 patients suffering from documented decline of cognitive function (in the absence of overt dementia) will be studied. In this placebo-controlled, double-blinded study, the 12 recruited subjects who have met the screening criteria will be randomized to receive 72 g of grape powder per day or placebo. The subjects will undergo a baseline brain PET study with the radiotracer [F - 18] fluorodeoxyglucose (FDG). In addition, neuropsychological assessments will be performed at baseline and six months after initiation of therapy. Follow-up PET scans will also be obtained at six months to assess the changes in metabolism occurring with each therapy regimen.
Study design
- 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Cognitive deficit and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline which the patient's physician deems to be reliable.
- If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
- Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
- Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.
Key exclusion criteria (6 listed)
- Subjects under age 65 will not be recruited, 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.
- Already diagnosed with Alzheimer's disease or other cause of dementia
- Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
- Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.)
- Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
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 6 months | Dietary supplement | Grape Powder |
| Placebo Powder36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 months | Dietary supplement | Placebo Powder |
Primary outcome
Change from baseline in neuropsychological (cognitive, functional) test results
Time frame: baseline and 6 months
Change from baseline in regional cerebral metabolism
Time frame: baseline and 6 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 4 Dec 2014.
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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, Ph.D. 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 1 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 4 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 4 Dec 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from baseline in neuropsychological (cognitive, functional) test results (time frame: baseline and 6 months). The study lists 2 primary outcomes in all. 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 4 Dec 2014.