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临床试验/NCT02751866
NCT02751866进行中(未招募)不适用

Early Intervention in Cognitive Aging

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250
试验地点
2
主要终点
Insulin resistance

研究概览

简要总结

Nutritional intervention in overweight middle aged individuals with subjective memory complaints.

详细描述

Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.

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
Double (Participant, Investigator)

盲法说明

There is no blind in the dietary intervention given that participants are aware of the nature of the foods they consume. However, each dietary approach is described as healthy. In the berry supplementation studies, there is double blinding using berry fruit and placebo powders that are packaged with a code.

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • overweight; subjective memory complaints

排除标准

  • diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse

结局指标

主要结局

Insulin resistance

时间窗: Eight or 12 weeks after enrollment

HOMA-IR will be derived from fasting glucose and insulin

Cognitive function

时间窗: Eight or 12 weeks after enrollment

Performances on examiner-adminstered instruments assessing memory function

次要结局

  • Long term glucose concentration(Eight or 12 weeks after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Krikorian

Professor

University of Cincinnati

研究点 (2)

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