Lifestyle Intervention Program for Cognitive Impairment

Cedars-Sinai Medical Center150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

150

Conditions

Mild Cognitive Impairment

Interventions

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.