Lifestyle Intervention Program for Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-domain Lifestyle Intervention Protocol to Detect Changes in Retinal Amyloid Among Individuals With Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: BBH-1001 Brain Health Supplement
* Other: Lifestyle Intervention
* Dietary Supplement: Brain Health Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 55 years of age Experiencing memory, or cognitive problems Exclusion Criteria: Patients < 55 years of age Previously diagnosed dementia; suspected dementia after clinical assessment by study physician at screening visit Mini Mental State Examination (MMSE) score less than 20 points Disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, psychiatric disease, symptomatic cardiovascular disease, revascularization within 1 year previously) Unable to safely change diet Patients without the means to visit the clinic on the assigned dates Patients that cannot comply with the data gathering needs of the study Severe loss of vision, hearing, or communicative ability Disorders preventing cooperation as judged by the study physician Coincident participation in another intervention trial Allergy to any ingredient in the supplement or placebo (i.e. soybean oil) Patients with gallstones due to possible interactions with turmeric Participants who are unable to provide clearance from their physician to participate in the physical activity training, as well as confirmed by Dr. Sherzai during the neurological exam.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BBH-1001 Brain Health Supplement<br>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). | Dietary Supplement: BBH-1001 Brain Health Supplement<br>* Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.<br>Other: Lifestyle Intervention<br>* All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.<br>|
| Placebo Comparator: Brain Health Placebo<br>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). | Other: Lifestyle Intervention<br>* All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.<br>Dietary Supplement: Brain Health Placebo<br>* Treatment with placebo consisting of soybean oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory