Lifestyle Intervention Program for Cognitive Impairment
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Mild Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT02741804
- Run by
- Cedars-Sinai Medical Center
- People needed
- 150
- Starts
- 2016-05-01
- Expected to finish
- 2019-05-01
- Last updated by the study team
- 2016-06-27
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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