Clinical trial NCT02741804: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Memory
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in retinal amyloid burden, as measured by retinal amyloid scan.
timeFrame: baseline and 18 months
Secondary outcomes:
measure: Change in Neuropsychology
timeFrame: baseline and 18 months
measure: Diagnosis of Dementia
timeFrame: baseline and 7-10 years
measure: Change in Neuroimaging
timeFrame: baseline and 18 months
measure: Change in Lab Results
timeFrame: baseline and 18 months
measure: Change in Vascular Risk Factors
timeFrame: baseline and 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ayesha Sherzai, MD
role: PRINCIPAL_INVESTIGATOR
References: