A Multi-domain Lifestyle Intervention Protocol to Detect Changes in Retinal Amyloid Among Individuals With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in retinal amyloid burden, as measured by retinal amyloid scan.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 55 years of age
- •Experiencing memory, or cognitive problems
排除标准
- •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.
结局指标
主要结局
Change in retinal amyloid burden, as measured by retinal amyloid scan.
时间窗: 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.
次要结局
- 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)
研究者
Ayesha Sherzai, MD
Staff Physician
Cedars-Sinai Medical Center