The Cognitive Resilience Study

Alzheimer Disease Clinical Trial

— CogRes  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016702
• Other study ID #: Pro00078117
• Secondary ID: P30AG028716-11S1
• Status: Completed
• Phase: N/A
• First received: January 9, 2017
• Last updated: August 11, 2017
• Start date: February 27, 2017
• Est. completion date: August 9, 2017

Study information

• Verified date: December 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 9, 2017
• Est. primary completion date: August 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 58 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in reaction time during memory testing during 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.	Measured immediately during one hour fMRI
Primary	Change in reaction time during executive function testing during 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.	Measured immediately during one hour fMRI
Primary	Change in accuracy during memory testing during gait task	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.	Measured immediately during one hour gait session
Primary	Change in reaction time during executive function testing during gait task	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.	Measured immediately during one hour gait session
Secondary	Change in accuracy during memory testing during fMRI	Secondary dependent variables are accuracy (% correct) when comparing a neutral memory task to a stress condition.	Measured immediately during one hour fMRI
Secondary	Change in accuracy during executive function testing during fMRI	Secondary dependent variables are accuracy (% correct) when comparing a neutral memory task to a stress condition.	Measured immediately during one hour fMRI
Secondary	Brain activation during memory testing during 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.	Measured immediately during one hour fMRI
Secondary	Brain activation during executive function testing during 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.	Measured immediately during one hour fMRI
Secondary	Change in gait performance provoked by memory dual tasking	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.	Measured immediately during one hour gait session
Secondary	Change in gait performance provoked by executive function dual tasking	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.	Measured immediately during one hour gait session