An interventional study of BBH-1001 Brain Health Supplement and Lifestyle Intervention in Mild Cognitive Impairment, sponsored by Cedars-Sinai Medical Center. Status unknown at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2016-06-27.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Prevention
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 150 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: 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).
Other: Lifestyle Intervention · Dietary Supplement: Brain Health Placebo
Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.
All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
Treatment with placebo consisting of soybean oil
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.
Time frame: baseline and 18 months
Change in Neuropsychology
1) Cognitive performance measured by Neuropsychological Test Battery, evaluating several cognitive domains, which are sensitive measures for mild cognitive changes
Time frame: 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.
Time frame: baseline and 7-10 years
Change in Neuroimaging
3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).
Time frame: baseline and 18 months
Change in Lab Results
4) Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels)
Time frame: baseline and 18 months
Change in Vascular Risk Factors
5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)
Time frame: baseline and 18 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center