Lifestyle Intervention Program for Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Other: Lifestyle InterventionDietary Supplement: BBH-1001 Brain Health SupplementDietary Supplement: Brain Health Placebo
- Registration Number
- NCT02741804
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Age ≥ 55 years of age
- Experiencing memory, or cognitive problems
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brain Health Placebo Lifestyle Intervention 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). BBH-1001 Brain Health Supplement BBH-1001 Brain Health Supplement 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). BBH-1001 Brain Health Supplement Lifestyle Intervention 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). Brain Health Placebo Brain Health Placebo 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).
- Primary Outcome Measures
Name Time Method Change in retinal amyloid burden, as measured by retinal amyloid scan. baseline and 18 months 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.
- Secondary Outcome Measures
Name Time Method Change in Neuropsychology baseline and 18 months 1) Cognitive performance measured by Neuropsychological Test Battery, evaluating several cognitive domains, which are sensitive measures for mild cognitive changes
Diagnosis of Dementia baseline and 7-10 years 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.
Change in Neuroimaging baseline and 18 months 3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).
Change in Lab Results baseline and 18 months 4) Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels)
Change in Vascular Risk Factors baseline and 18 months 5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)
Trial Locations
- Locations (1)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States