Alzheimer DiseaseCogResNCT03016702
The Cognitive Resilience Study
A study testing Cognitive stress tests during functional MRI and Cognitive stress tests during gait task in people with Alzheimer Disease, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 58 to 70 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Cognitive stress tests during functional MRI and Cognitive stress tests during gait task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 9 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to walk 2 minutes without assistive device or assistance from another person
- Cognitive function within normal limits
Who cannot join
- Unable to undergo MRI
- Left handed
- Red/Green Color Blind
- Severe vision impairments
- Diagnosis of Alzheimer's Disease or other dementia/memory problem
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The Cognitive Resilience Study: Stress Tests for Alzheimer's Disease
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Cognitive stress tests during functional MRI, Cognitive stress tests during gait task
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stress tests during functional MRIOther
Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function while undergoing fMRI.
Cognitive stress tests during gait taskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cognitive stress tests during functional MRI; Other: Cognitive stress tests during gait task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: Measured immediately during one hour gait session
Secondary outcomes (6)
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: Measured immediately during one hour fMRI
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: Measured immediately during one hour fMRI
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: Measured immediately during one hour fMRI
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: Measured immediately during one hour fMRI
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: Measured immediately during one hour gait session
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: Measured immediately during one hour gait session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start27 Feb 2017
- Primary completion9 Aug 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Bryan Alzheimer's Disease Research Center, Duke University Center for the Study of Aging and Human Development
- Responsible party
- Sponsor
- Investigators
- Heather Whitson, MD, MHS, Principal investigator, Duke University Aging Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016702
- Sponsor's protocol ID
- Pro00078117
- Other IDs
- P30AG028716-11S1, SPS # 224571
- Acronym
- CogRes
- Status last verified
- Dec 2016
- First submitted
- 9 Jan 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive Resilience Study: Stress Tests for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03016702
- Acronym / sponsor ID
- CogRes / Pro00078117
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Bryan Alzheimer's Disease Research Center, Duke University Center for the Study of Aging and Human Development
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Alzheimer's Disease | Experimental | Other: Cognitive stress tests during functional MRI, Other: Cognitive stress tests during gait taskThis 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. |
| Low Risk Alzheimer Disease | Experimental | Other: Cognitive stress tests during functional MRI, Other: Cognitive stress tests during gait taskThis 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. |
Who may qualify
- Ages
- 58 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to walk 2 minutes without assistive device or assistance from another person
- Cognitive function within normal limits
Key exclusion criteria (5 listed)
- Unable to undergo MRI
- Left handed
- Red/Green Color Blind
- Severe vision impairments
- Diagnosis of Alzheimer's Disease or other dementia/memory problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive stress tests during functional MRISubjects will undergo progressively more complex cognitive stress tests that assess memory and executive function while undergoing fMRI. | Other | High Risk Alzheimer's Disease, Low Risk Alzheimer Disease |
| Cognitive stress tests during gait taskSubjects 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. | Other | High Risk Alzheimer's Disease, Low Risk Alzheimer Disease |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Change in accuracy during memory testing during fMRI
Time frame: Measured immediately during one hour fMRI
Change in accuracy during executive function testing during fMRI
Time frame: Measured immediately during one hour fMRI
Brain activation during memory testing during fMRI
Time frame: Measured immediately during one hour fMRI
Brain activation during executive function testing during fMRI
Time frame: Measured immediately during one hour fMRI
Change in gait performance provoked by memory dual tasking
Time frame: Measured immediately during one hour gait session
Change in gait performance provoked by executive function dual tasking
Time frame: Measured immediately during one hour gait session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Whitson, MD, MHS principal investigator
Duke University Aging Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stress tests during functional MRI and Cognitive stress tests during gait task in people with Alzheimer Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reaction time during memory testing during fMRI (time frame: Measured immediately during one hour fMRI). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.