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Lifestyle Intervention Program for Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02741804
Recruitment Status : Unknown
Verified June 2016 by Ayesha Sherzai, MD, Cedars-Sinai Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 18, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Ayesha Sherzai, MD, Cedars-Sinai Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dietary Supplement: BBH-1001 Brain Health Supplement Other: Lifestyle Intervention Dietary Supplement: Brain Health Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Multi-domain Lifestyle Intervention Protocol to Detect Changes in Retinal Amyloid Among Individuals With Mild Cognitive Impairment
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Change in Neuroimaging [ Time Frame: baseline and 18 months ]
    3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).

  4. 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)

  5. Change in Vascular Risk Factors [ Time Frame: baseline and 18 months ]
    5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741804


Contacts
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Contact: Wendy Weissberg, BS 3104235357 weissbergg@cshs.org
Contact: Ayesha Sherzai, MD 4243154550 ayesha.sherzai@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Contact: Wendy Weissberg    310-423-5357    weissbergg@cshs.org   
Contact: Georgia Rochester    3104236587    georgia.rochester@cshs.org   
Sub-Investigator: Dean Sherzai, MD, MAS         
Principal Investigator: Ayesha Sherzai, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Ayesha Sherzai, MD Cedars-Sinai Medical Center
More Information
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Responsible Party: Ayesha Sherzai, MD, Staff Physician, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02741804    
Other Study ID Numbers: 41387
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ayesha Sherzai, MD, Cedars-Sinai Medical Center:
Memory
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders