Clinical Trial: Lifestyle Intervention Program for Cognitive Impairment

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Cedars-Sinai Medical Center

Current Primary Outcome: Change in retinal amyloid burden, as measured by retinal amyloid scan. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Neuropsychology [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline and 18 months ]
    3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).
  • Change in Lab Results [ Time Frame: baseline and 18 months ]
    4) Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels)
  • Change in Vascular Risk Factors [ Time Frame: baseline and 18 months ]
    5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)


Original Secondary Outcome: Same as current

Information By: Cedars-Sinai Medical Center

Dates:
Date Received: April 7, 2016
Date Started: May 2016
Date Completion: May 2019
Last Updated: June 23, 2016
Last Verified: June 2016