Lifestyle Intervention Program for Cognitive Impairment

NCT02741804 | Unknown

• 1 other identifier: 41387
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Memory

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 18 months

Secondary Outcomes (5)

• Change in Neuropsychology

  baseline and 18 months

• Diagnosis of Dementia

  baseline and 7-10 years

• Change in Neuroimaging

  baseline and 18 months

• Change in Lab Results

  baseline and 18 months

• Change in Vascular Risk Factors

  baseline and 18 months

Study Arms (2)

BBH-1001 Brain Health Supplement

ACTIVE COMPARATOR

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; Other: Lifestyle Intervention

Brain Health Placebo

PLACEBO COMPARATOR

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; Dietary Supplement: Brain Health Placebo

Interventions

BBH-1001 Brain Health Supplement DIETARY_SUPPLEMENT

Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.

BBH-1001 Brain Health Supplement

Lifestyle Intervention OTHER

All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.

BBH-1001 Brain Health Supplement; Brain Health Placebo

Brain Health Placebo DIETARY_SUPPLEMENT

Treatment with placebo consisting of soybean oil

Brain Health Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 55 years of age
• Experiencing memory, or cognitive problems

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ayesha Sherzai, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Weissberg, BS

CONTACT

3104235357; weissbergg@cshs.org

Ayesha Sherzai, MD

CONTACT

4243154550; ayesha.sherzai@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 18, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 27, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)