The Cognitive Resilience Study

NCT03016702 | Completed DMC

• 3 other identifiers: Pro00078117P30AG028716-11S1SPS # 224571
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Change in accuracy during memory testing during fMRI

  Measured immediately during one hour fMRI

• Change in accuracy during executive function 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 memory dual tasking

  Measured immediately during one hour gait session

Study Arms (2)

High Risk Alzheimer's Disease

EXPERIMENTAL

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; Other: Cognitive stress tests during gait task

Low Risk Alzheimer Disease

EXPERIMENTAL

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; Other: Cognitive stress tests during gait task

Interventions

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.

High Risk Alzheimer's Disease; Low Risk Alzheimer Disease

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.

High Risk Alzheimer's Disease; Low Risk Alzheimer Disease

Eligibility Criteria

• Age: 58 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Heather Whitson, MD, MHS

  Duke University Aging Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 10, 2017
• Study Start: February 27, 2017
• Primary Completion: August 9, 2017
• Study Completion: August 9, 2017
• Last Updated: August 14, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)