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Lifestyle Intervention Program for Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BBH-1001 Brain Health Supplement
Lifestyle Intervention
Brain Health Placebo
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Memory

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BBH-1001 Brain Health Supplement

Brain Health Placebo

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Neuropsychology
1) Cognitive performance measured by Neuropsychological Test Battery, evaluating several cognitive domains, which are sensitive measures for mild cognitive changes
Diagnosis of Dementia
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
3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).
Change in Lab Results
4) Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels)
Change in Vascular Risk Factors
5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)

Full Information

First Posted
April 7, 2016
Last Updated
June 23, 2016
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02741804
Brief Title
Lifestyle Intervention Program for Cognitive Impairment
Official Title
A Multi-domain Lifestyle Intervention Protocol to Detect Changes in Retinal Amyloid Among Individuals With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Memory

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BBH-1001 Brain Health Supplement
Arm Type
Active Comparator
Arm 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).
Arm Title
Brain Health Placebo
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
BBH-1001 Brain Health Supplement
Intervention Description
Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.
Intervention Type
Other
Intervention Name(s)
Lifestyle Intervention
Intervention Description
All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Brain Health Placebo
Intervention Description
Treatment with placebo consisting of soybean oil
Primary Outcome Measure Information:
Title
Change in retinal amyloid burden, as measured by retinal amyloid scan.
Description
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.
Time Frame
baseline and 18 months
Secondary Outcome Measure Information:
Title
Change in Neuropsychology
Description
1) Cognitive performance measured by Neuropsychological Test Battery, evaluating several cognitive domains, which are sensitive measures for mild cognitive changes
Time Frame
baseline and 18 months
Title
Diagnosis of Dementia
Description
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.
Time Frame
baseline and 7-10 years
Title
Change in Neuroimaging
Description
3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).
Time Frame
baseline and 18 months
Title
Change in Lab Results
Description
4) Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels)
Time Frame
baseline and 18 months
Title
Change in Vascular Risk Factors
Description
5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)
Time Frame
baseline and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Weissberg, BS
Phone
3104235357
Email
weissbergg@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Sherzai, MD
Phone
4243154550
Email
ayesha.sherzai@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Sherzai, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Weissberg
Phone
310-423-5357
Email
weissbergg@cshs.org
First Name & Middle Initial & Last Name & Degree
Georgia Rochester
Phone
3104236587
Email
georgia.rochester@cshs.org
First Name & Middle Initial & Last Name & Degree
Dean Sherzai, MD, MAS
First Name & Middle Initial & Last Name & Degree
Ayesha Sherzai, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Lifestyle Intervention Program for Cognitive Impairment

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