NCT02741804

Lifestyle Intervention Program for Cognitive Impairment

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BBH-1001 Brain Health Supplement	Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.
OTHER	Lifestyle Intervention	All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
DIETARY_SUPPLEMENT	Brain Health Placebo	Treatment with placebo consisting of soybean oil

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2016-04-18
• Last updated: 2016-06-27

Locations

1 site across 1 country: United States