Clinical trial NCT03016702: The Cognitive Resilience Study
Official title: The Cognitive Resilience Study: Stress Tests for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Bryan Alzheimer's Disease Research Center
name: Duke University Center for the Study of Aging and Human Development
First posted: 2017-01-10
Enrollment: 29
Sex: ALL
Minimum age (years): 58
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Able to walk 2 minutes without assistive device or assistance from another person
* Cognitive function within normal limits

Exclusion Criteria:

* Unable to undergo MRI
* Left handed
* Red/Green Color Blind
* Severe vision impairments
* Diagnosis of Alzheimer's Disease or other dementia/memory problem

Primary outcomes:
measure: Change in reaction time during memory testing during fMRI
timeFrame: Measured immediately during one hour fMRI
measure: Change in reaction time during executive function testing during fMRI
timeFrame: Measured immediately during one hour fMRI
measure: Change in accuracy during memory testing during gait task
timeFrame: Measured immediately during one hour gait session
measure: Change in reaction time during executive function testing during gait task
timeFrame: Measured immediately during one hour gait session
Secondary outcomes:
measure: Change in accuracy during memory testing during fMRI
timeFrame: Measured immediately during one hour fMRI
measure: Change in accuracy during executive function testing during fMRI
timeFrame: Measured immediately during one hour fMRI
measure: Brain activation during memory testing during fMRI
timeFrame: Measured immediately during one hour fMRI
measure: Brain activation during executive function testing during fMRI
timeFrame: Measured immediately during one hour fMRI
measure: Change in gait performance provoked by memory dual tasking
timeFrame: Measured immediately during one hour gait session
measure: Change in gait performance provoked by executive function dual tasking
timeFrame: Measured immediately during one hour gait session
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Aging Center
name: Heather Whitson, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: