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Completed

NCT Number: NCT03016702

The Cognitive Resilience Study

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

58 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive stress tests during functional MRI

Other

Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function while undergoing fMRI.

Cognitive stress tests during gait task

Other

Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function both in sitting and while ambulating on a force sensor mat.

Primary outcomes

  1. Change in reaction time during memory testing during fMRI

    Time frame: 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.

  2. Change in reaction time during executive function testing during fMRI

    Time frame: 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.

  3. Change in accuracy during memory testing during gait task

    Time frame: 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.

  4. Change in reaction time during executive function testing during gait task

    Time frame: 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.

Secondary outcomes

  1. Change in accuracy during memory testing during fMRI

    Time frame: Measured immediately during one hour fMRI

    Secondary dependent variables are accuracy (% correct) when comparing a neutral memory task to a stress condition.

  2. Change in accuracy during executive function testing during fMRI

    Time frame: Measured immediately during one hour fMRI

    Secondary dependent variables are accuracy (% correct) when comparing a neutral memory task to a stress condition.

  3. Brain activation during memory testing during fMRI

    Time frame: Measured immediately during one hour fMRI

    Group differences in brain activation provoked by the memory stress condition will be assessed using brain maps that compare block-average BOLD signal for resting vs neutral task, resting vs stress task, neutral vs stress task.

  4. Brain activation during executive function testing during fMRI

    Time frame: Measured immediately during one hour fMRI

    Group differences in brain activation provoked by the executive function stress condition will be assessed using brain maps that compare block-average BOLD signal for resting vs neutral task, resting vs stress task, neutral vs stress task.

  5. Change in gait performance provoked by memory dual tasking

    Time frame: Measured immediately during one hour gait session

    The secondary dependent variable will be DTEmob = (Dual task[mobility score] - Single Task[mobility score] / Single task [mobility score]. For both memory and executive tasks, the mobility measure in the DTEmob calculation will be gait speed.

  6. Change in gait performance provoked by executive function dual tasking

    Time frame: Measured immediately during one hour gait session

    The secondary dependent variable will be DTEmob = (Dual task[mobility score] - Single Task[mobility score] / Single task [mobility score]. For both memory and executive tasks, the mobility measure in the DTEmob calculation will be gait speed.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Bryan Alzheimer's Disease Research Center
  • Duke University Center for the Study of Aging and Human Development
  • National Institute on Aging (NIA)

Registry information

Official study title

The Cognitive Resilience Study: Stress Tests for Alzheimer's Disease

Acronym: CogRes

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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