Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Cognitive Resilience Study (CogRes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03016702
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : August 14, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Bryan Alzheimer's Disease Research Center
Duke University Center for the Study of Aging and Human Development
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Cognitive stress tests during functional MRI Other: Cognitive stress tests during gait task Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Cognitive Resilience Study: Stress Tests for Alzheimer's Disease
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : August 9, 2017
Actual Study Completion Date : August 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Cognitive stress tests during functional MRI
Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function while undergoing fMRI.

Other: Cognitive stress tests during gait task
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.

Experimental: 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.
Other: Cognitive stress tests during functional MRI
Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function while undergoing fMRI.

Other: Cognitive stress tests during gait task
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   58 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016702


Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute on Aging (NIA)
Bryan Alzheimer's Disease Research Center
Duke University Center for the Study of Aging and Human Development
Investigators
Layout table for investigator information
Principal Investigator: Heather Whitson, MD, MHS Duke University Aging Center

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03016702     History of Changes
Other Study ID Numbers: Pro00078117
P30AG028716-11S1 ( U.S. NIH Grant/Contract )
SPS # 224571 ( Other Identifier: Duke University )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders