Lifestyle Intervention Program for Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02741804
• Other study ID #: 41387
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2016
• Last updated: June 23, 2016
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: June 2016
• Source: Cedars-Sinai Medical Center
• Contact: Wendy Weissberg, BS
• Phone: 3104235357
• Email: weissbergg[@]cshs.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.

Dietary Supplement:
• Brain Health Placebo
Treatment with placebo consisting of soybean oil

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Neuropsychology	1) Cognitive performance measured by Neuropsychological Test Battery, evaluating several cognitive domains, which are sensitive measures for mild cognitive changes	baseline and 18 months	No
Secondary	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.	baseline and 7-10 years	No
Secondary	Change in Neuroimaging	3) Neuroimaging via data review (structural and functional brain MRI and FDG-PET).	baseline and 18 months	No
Secondary	Change in Lab Results	4) Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels)	baseline and 18 months	Yes
Secondary	Change in Vascular Risk Factors	5) Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)	baseline and 18 months	Yes