Lifestyle Intervention Program for Cognitive Impairment

Cedars-Sinai Medical Center

Status: Unknown

Conditions: Mild Cognitive Impairment

Treatments: Other: Lifestyle Intervention; Dietary Supplement: BBH-1001 Brain Health Supplement; Dietary Supplement: Brain Health Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02741804

41387

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

BBH-1001 Brain Health Supplement

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: BBH-1001 Brain Health Supplement

Other: Lifestyle Intervention

Brain Health Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Brain Health Placebo

Other: Lifestyle Intervention