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The purpose of the Lifestyle Intervention Study is to investigate the influence of a micronutrient supplement in combination with a comprehensive lifestyle intervention program on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Patients will be placed on supplement or placebo throughout their 18-month study participation. Patients will also be given lifestyle training on nutrition, physical activity, cognitive and social activity, meditation and sleep, which have all been proven to positively affect cognition over time. Throughout their participation, patients' cognitive functioning will be monitored with comprehensive imaging, neuropsychological testing, blood testing and study compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBH-1001 Brain Health Supplement | Active Comparator | Patients will be given supplement containing ingredients all approved by the FDA: Turmeric (125mg), fisetin (16.65mg), green tea leaf extract (17.5mg), EPA (75mg), DHA (150mg) and Vitamin D3 (250IU). Patients will take 4 softgels once per day for entire study duration (18 months). |
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| Brain Health Placebo | Placebo Comparator | Patients will be given a pill resembling the study supplement, but instead consisting of Soybean oil (608mg). Patients will take 4 softgels once per day for the entire study duration (18 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBH-1001 Brain Health Supplement | Dietary Supplement | Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in retinal amyloid burden, as measured by retinal amyloid scan. | Patients will be given a retinal scan at baseline, 6 months, 12 months and end of study (18 months). The retinal scanner is an device that measures the buildup of amyloid proteins in the brain via imaging of the eye. The change in amyloid buildup between each time point will be measured to determine effect of the interventions. | baseline and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropsychology | 1) Cognitive performance measured by Neuropsychological Test Battery, evaluating several cognitive domains, which are sensitive measures for mild cognitive changes | baseline and 18 months |
| Diagnosis of Dementia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Weissberg, BS | Contact | 3104235357 | weissbergg@cshs.org | |
| Ayesha Sherzai, MD | Contact | 4243154550 | ayesha.sherzai@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Ayesha Sherzai, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Lifestyle Intervention | Other | All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity. |
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| Brain Health Placebo | Dietary Supplement | Treatment with placebo consisting of soybean oil |
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2) Incidence dementia and Alzheimer's disease (according to standard criteria, NINCDS-ADRDA). An extended follow-up of at least 7-10 years is needed to investigate the effect of the intervention on this outcome.
| baseline and 7-10 years |
| Change in Neuroimaging | 3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET). | baseline and 18 months |
| Change in Lab Results | 4) Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels) | baseline and 18 months |
| Change in Vascular Risk Factors | 5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel) | baseline and 18 months |