Lifestyle Intervention Program for Cognitive Impairment

June 23, 2016 updated by: Ayesha Sherzai, MD, Cedars-Sinai Medical Center

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BBH-1001 Brain Health Supplement
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
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.
Placebo Comparator: Brain Health Placebo
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 18 months
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.
baseline and 7-10 years
Change in Neuroimaging
Time Frame: baseline and 18 months
3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).
baseline and 18 months
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)
baseline and 18 months
Change in Vascular Risk Factors
Time Frame: baseline and 18 months
5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)
baseline and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Ayesha Sherzai, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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