The Cognitive Resilience Study: Stress Tests for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in reaction time during memory testing during fMRI
研究概览
简要总结
The purpose of this study is to test whether two new cognitive "stress tests" may help distinguish between people at lower or higher genetic risk of Alzheimer's Disease. The investigators are trying to understand how these cognitive "stress tests" work in people who have not been diagnosed with Alzheimer's Disease and are not exhibiting symptoms of Alzheimer's Disease. Study subjects will undergo testing of memory and executive function during functional magnetic resonance image (fMRI) of the brain and also during a walking test.
详细描述
The objective is to establish the feasibility and evaluate the role of two novel tests of cognitive resilience for use in identification of early Alzheimer's Disease. The investigators hypothesize that exposure to the controlled stressor of increased cognitive task demand will evoke measurable phenotypes of poor resilience, which will be associated with Alzheimer's Disease risk. The study will include 30 volunteer participants from the Duke Alzheimer's Disease Prevention Registry (ADPR). The ADPR cohort has been characterized according to genetic risk based on genotype at loci associated with Alzheimer's Disease. The investigators will recruit a sample from the ADPR that includes 15 people in the "genetic high risk" group and 15 people, matched by age, in the "genetic low risk" group. Investigators and experimenters are masked to the genetic profile of all participants. All participants will undergo two cognitive stress test protocols. Both protocols include memory and executive function components, one done during functional MRI and one while ambulating on a force sensor mat. Both cognitive stress tests are minimal risk; the primary risk of this study is loss of confidentiality. Genetic testing is not performed as part of this protocol; the sampling strategy will make use of prior genetic testing results, which are not revealed to the primary investigators. In addition to determining whether scores on the two novel tests statistically differ by AD risk groups, the project will establish the tests' feasibility and characteristics for use in future study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 58 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to walk 2 minutes without assistive device or assistance from another person
- •Cognitive function within normal limits
排除标准
- •Unable to undergo MRI
- •Left handed
- •Red/Green Color Blind
- •Severe vision impairments
- •Diagnosis of Alzheimer's Disease or other dementia/memory problem
研究组 & 干预措施
High Risk Alzheimer's Disease
This group includes subjects with APOEe4 homozygotes, the genetic profile associated with the highest risk for late-onset AD and the next highest-risk group, APOE e3/e4 heterozygotes. To target the highest risk among the APOEe3/e4 heterozygotes in ADPR, the study team will consider TOMM40-'523 variant status. Although there is uncertainty about the independent role of TOMM40 in AD risk-stratification (especially across racial/ethnic groups), this study will use TOMM40-'523 to guide heterozygote selection based on findings that among e3/e4 heterozygotes, longer TOMM40-523 polyT sequences are associated with earlier age of onset for late-onset AD.
干预措施: Cognitive stress tests during functional MRI (Other)
High Risk Alzheimer's Disease
This group includes subjects with APOEe4 homozygotes, the genetic profile associated with the highest risk for late-onset AD and the next highest-risk group, APOE e3/e4 heterozygotes. To target the highest risk among the APOEe3/e4 heterozygotes in ADPR, the study team will consider TOMM40-'523 variant status. Although there is uncertainty about the independent role of TOMM40 in AD risk-stratification (especially across racial/ethnic groups), this study will use TOMM40-'523 to guide heterozygote selection based on findings that among e3/e4 heterozygotes, longer TOMM40-523 polyT sequences are associated with earlier age of onset for late-onset AD.
干预措施: Cognitive stress tests during gait task (Other)
Low Risk Alzheimer Disease
This group includes e2/e2 homozygotes (rare) and e2/e3 heterozygotes. the genetic profile associated with low risk for late-onset development of Alzheimer's disease.
干预措施: Cognitive stress tests during functional MRI (Other)
Low Risk Alzheimer Disease
This group includes e2/e2 homozygotes (rare) and e2/e3 heterozygotes. the genetic profile associated with low risk for late-onset development of Alzheimer's disease.
干预措施: Cognitive stress tests during gait task (Other)
结局指标
主要结局
Change in reaction time during memory testing during fMRI
时间窗: Measured immediately during one hour fMRI
The primary dependent variable will be change in reaction time when comparing a neutral memory task to a stress condition. Reaction time will be in ms and will be recorded while the subject is undergoing fMRI.
Change in reaction time during executive function testing during gait task
时间窗: Measured immediately during one hour gait session
The primary dependent variable will be DTEcog = (Dual task \[cognitive score\] - Single Task \[cognitive score\] / Single task \[cognitive score\]. For the executive task, the primary cognitive measure in the DTEcog calculation will be reaction time.
Change in reaction time during executive function testing during fMRI
时间窗: Measured immediately during one hour fMRI
The primary dependent variable will be change in reaction time when comparing a neutral executive function task to a stress condition. Reaction time will be in ms and will be recorded while the subject is undergoing fMRI.
Change in accuracy during memory testing during gait task
时间窗: Measured immediately during one hour gait session
The primary dependent variable will be DTEcog = (Dual task \[cognitive score\] - Single Task \[cognitive score\] / Single task \[cognitive score\]. For the memory task, the primary cognitive measure will be the number of correct responses.
次要结局
- Change in gait performance provoked by memory dual tasking(Measured immediately during one hour gait session)
- Change in accuracy during memory testing during fMRI(Measured immediately during one hour fMRI)
- Brain activation during memory testing during fMRI(Measured immediately during one hour fMRI)
- Brain activation during executive function testing during fMRI(Measured immediately during one hour fMRI)
- Change in gait performance provoked by executive function dual tasking(Measured immediately during one hour gait session)
- Change in accuracy during executive function testing during fMRI(Measured immediately during one hour fMRI)