Alzheimer DiseaseVMAPNCT05372159
Vanderbilt Memory and Aging Project
An observational study of Alzheimer Disease and Aging, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study will use an observational cohort to cross-sectionally and longitudinally relate vascular health to clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among aging adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Aging, Aged, 80 and Over
- What is being tested?
- none, observational study
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2012to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community-dwelling older adults.
Who may be able to join
- Participants recruited will include 1,000 adults age 50 and older.
- After the eligibility visit, a small portion of participants (~150) enrolling must meet diagnostic criteria for mild cognitive impairment according to a clinician diagnosis and/or medical records (i.e., participants must have mild memory or cognitive problems, but they must be free of any functional problems and not have Alzheimer's disease or another form of dementia). The remaining ~850 participants will be cognitively unimpaired adults age 50 and older.
- Because the neuropsychological tests used to measure cognitive performance are validated on English-speaking populations, we require that English be the primary language of all participants.
Who cannot join
- No available reliable study partner
- History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., stroke, epilepsy, multiple sclerosis, Parkinson's disease, dementia), or head injury with significant loss of consciousness. These exclusion criteria have been applied because they affect brain structure and function.
- Diagnosis of congestive heart failure
- Diagnosis of atrial fibrillation or other heart arrhythmia
- Diagnosis of Chronic obstructive pulmonary disease
- Diagnosis of cancer (current)
- History of serious alcohol or drug abuse (past or current)
- Participants unable to undergo MRI will be excluded. Reasons may include: a. Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). b. Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced. c. Subjects who have cerebral aneurysm clips. d. Subjects who may have shrapnel imbedded in their bodies (e.g., from war wounds), metal workers and machinists (e.g., potential for metallic fragments in or near the eyes). e. Subjects who are pregnant. Given that the minimum age of recruitment for the current study is 50 years of age, it is unlikely that prospective participants will be excluded because of pregnancy. f. Subjects who have excessive amounts of metal dental work based on records released by their dentist.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This study will use an observational cohort to cross-sectionally and longitudinally relate vascular health to clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical covariates, we will test the hypothesis that vascular health is associated with clinical, brain magnetic resonance imaging (MRI), neuropsychological, and cerebrospinal fluid markers of early cerebrovascular and Alzheimer's disease changes (i.e., prior to the onset of significant cognitive decline or dementia). Secondarily, we will examine medical and genetic factors that might mediate associations between vascular health and brain aging, such as inflammatory processes, insulin resistance, and genetic factors (e.g., APOE, a susceptibility risk factor for dementia). Findings will advance knowledge regarding the role that vascular health plays in brain aging.
Read the detailed description
As the population ages, Alzheimer's disease and dementia are becoming a public health crisis. In the initial cycle, the Vanderbilt Memory \& Aging Project was established to examine cardiovascular function in relation to structural neuroimaging changes and cognition. The investigators tested whether associations were more prominent in clinically symptomatic individuals. The investigators successfully enrolled several hundred participants age 60 and older, data successfully supported multiple training grant opportunities (e.g., National Research Service Awards, Career Development Awards), and the investigators published numerous papers. The results suggest subclinical cardiovascular changes relate to worse cognition, white matter changes, and cerebral atrophy, especially in the hippocampus and other cortical regions primarily affected in Alzheimer's disease. Evidence to date supports the central hypothesis that well-established homeostatic mechanisms designed to protect cerebral blood supply become less effective with age, altering the integrity of cerebral hemodynamics, and lowering the threshold for neurodegenerative and cognitive changes. Interestingly, preliminary associations between subclinical cardiovascular integrity and cerebral hemodynamics are stronger among carriers of the apolipoprotein E ε4 (APOE-ε4) allele, an Alzheimer's disease genetic risk factor. Furthermore, findings are more prominent in cognitively unimpaired participants, suggesting subtle cardiac hemodynamic changes may act as an underrecognized precipitating contributor of neurodegeneration and corresponding cognitive decline, distinct from the exacerbating effects of overt cerebrovascular disease. In the next cycle, the investigators propose to better characterize underlying mechanisms linking early cardiac hemodynamic changes to abnormal brain aging in cognitively unimpaired participants, and test whether APOE-ε4 moderates the effect of vascular damage on brain health. The investigators will follow the existing cohort and supplement it with enrollment of several hundred cognitively unimpaired participants to increase statistical power for more comprehensive analyses. The new participants will complete serial longitudinal assessments with identical procedures plus lumbar puncture for cerebrospinal fluid acquisition. Innovative translational efforts leveraging sophisticated neuroimaging and molecular biomarkers are critical to better detect early, asymptomatic cardiac hemodynamic changes, which may be more influential in initiating downstream cerebrovascular and neurodegenerative processes than previously recognized.
- Conditions
- Alzheimer Disease, Aging, Aged, 80 and Over, Biomarkers, Brain, Case-Control Studies
- Being tested
- none, observational study
- Keywords
- Alzheimer's disease, biomarkers, brain MRI, cardiac MRI, mild cognitive impairment, vascular risk factors, longitudinal studies
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, observational studyOther
none, observational study
| Study group | Role | What they receive |
|---|---|---|
| Cognitively healthy adults | Eligible participants completed a 4-hour screening visit, and a consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. Receives: Other: none, observational study | |
| Cognitively impaired adults | Eligible participants completed a 4-hour screening visit, and a consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. Receives: Other: none, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter hyperintensities Volume
White matter lesion volume measured by FLAIR imaging modality
Measured: baseline to year five
Grey Matter Volume
Grey matter volume measured by T1 imaging modality
Measured: baseline to year five
Cerebral Blood Flow
Resting cerebral blood flow to brain regions measured by T3 perfusion
Measured: baseline to year five
Lacunar infarcts
Number of lacunar infarcts measured by MRI
Measured: baseline to year five
Small vessel microbleeds
Presence and number of microbleeds measured by MRI
Measured: baseline to year five
Left ventricular ejection fraction
Left ventricular ejection fraction measured by echocardiogram
Measured: baseline to year five
Cardiac output
Amount of blood the heart pumps from each ventricle per minute, litres per minute (L/min). Measured by echocardiogram
Measured: baseline to year five
Cardiac stroke volume
Stroke volume measured by echocardiogram
Measured: baseline to year five
Pulse Wave velocity
pulse wave velocity measured by cardiac MRI
Measured: baseline to year five
Cardiac Strain
Global longitudinal strain and global circumferential strain measured by cardiac MRI
Measured: baseline to year five
Biological marker for Alzheimer's disease
Tau, amyloid, neurodegenerative levels measured in cerebrospinal fluid samples
Measured: baseline to year five
Blood based biological marker for Alzheimer's disease
Tau, amyloid, neurodegenerative levels measured in blood samples
Measured: baseline to year five
APOE Genotype
APOE e4 allele status
Measured: baseline to year five
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start17 Sep 2012
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Angela Jefferson, Vanderbilt University Medical Center
- Investigators
- Angela Jefferson, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372159
- Sponsor's protocol ID
- 120158
- Other IDs
- K23AG045966, R01AG034962, F32AG046093, K24AG046373, R01NS100980, R01AG056534, F32AG058395, F31AG066358
- Acronym
- VMAP
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanderbilt Memory and Aging Project
- ClinicalTrials.gov ID
- NCT05372159
- Acronym / sponsor ID
- VMAP / 120158
- Conditions
- Alzheimer Disease, Aging, Aged, 80 and Over, Biomarkers, Brain, Case-Control Studies
- Keywords
- Alzheimer's disease, biomarkers, brain MRI, cardiac MRI, mild cognitive impairment, vascular risk factors, longitudinal studies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 17 Sep 2012 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 May 2022 (actual)
- 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.
This study will use an observational cohort to cross-sectionally and longitudinally relate vascular health to clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical covariates, we will test the hypothesis that vascular health is associated with clinical, brain magnetic resonance imaging (MRI), neuropsychological, and cerebrospinal fluid markers of early cerebrovascular and Alzheimer's disease changes (i.e., prior to the onset of significant cognitive decline or dementia). Secondarily, we will examine medical and genetic factors that might mediate associations between vascular health and brain aging, such as inflammatory processes, insulin resistance, and genetic factors (e.g., APOE, a susceptibility risk factor for dementia). Findings will advance knowledge regarding the role that vascular health plays in brain aging.
Detailed description
As the population ages, Alzheimer's disease and dementia are becoming a public health crisis. In the initial cycle, the Vanderbilt Memory \& Aging Project was established to examine cardiovascular function in relation to structural neuroimaging changes and cognition. The investigators tested whether associations were more prominent in clinically symptomatic individuals. The investigators successfully enrolled several hundred participants age 60 and older, data successfully supported multiple training grant opportunities (e.g., National Research Service Awards, Career Development Awards), and the investigators published numerous papers. The results suggest subclinical cardiovascular changes relate to worse cognition, white matter changes, and cerebral atrophy, especially in the hippocampus and other cortical regions primarily affected in Alzheimer's disease. Evidence to date supports the central hypothesis that well-established homeostatic mechanisms designed to protect cerebral blood supply become less effective with age, altering the integrity of cerebral hemodynamics, and lowering the threshold for neurodegenerative and cognitive changes. Interestingly, preliminary associations between subclinical cardiovascular integrity and cerebral hemodynamics are stronger among carriers of the apolipoprotein E ε4 (APOE-ε4) allele, an Alzheimer's disease genetic risk factor. Furthermore, findings are more prominent in cognitively unimpaired participants, suggesting subtle cardiac hemodynamic changes may act as an underrecognized precipitating contributor of neurodegeneration and corresponding cognitive decline, distinct from the exacerbating effects of overt cerebrovascular disease. In the next cycle, the investigators propose to better characterize underlying mechanisms linking early cardiac hemodynamic changes to abnormal brain aging in cognitively unimpaired participants, and test whether APOE-ε4 moderates the effect of vascular damage on brain health. The investigators will follow the existing cohort and supplement it with enrollment of several hundred cognitively unimpaired participants to increase statistical power for more comprehensive analyses. The new participants will complete serial longitudinal assessments with identical procedures plus lumbar puncture for cerebrospinal fluid acquisition. Innovative translational efforts leveraging sophisticated neuroimaging and molecular biomarkers are critical to better detect early, asymptomatic cardiac hemodynamic changes, which may be more influential in initiating downstream cerebrovascular and neurodegenerative processes than previously recognized.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitively healthy adults | – | Other: none, observational studyEligible participants completed a 4-hour screening visit, and a consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. |
| Cognitively impaired adults | – | Other: none, observational studyEligible participants completed a 4-hour screening visit, and a consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older adults.
Key inclusion criteria (3 listed)
- Participants recruited will include 1,000 adults age 50 and older.
- After the eligibility visit, a small portion of participants (~150) enrolling must meet diagnostic criteria for mild cognitive impairment according to a clinician diagnosis and/or medical records (i.e., participants must have mild memory or cognitive problems, but they must be free of any functional problems and not have Alzheimer's disease or another form of dementia). The remaining ~850 participants will be cognitively unimpaired adults age 50 and older.
- Because the neuropsychological tests used to measure cognitive performance are validated on English-speaking populations, we require that English be the primary language of all participants.
Key exclusion criteria (8 listed)
- No available reliable study partner
- History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., stroke, epilepsy, multiple sclerosis, Parkinson's disease, dementia), or head injury with significant loss of consciousness. These exclusion criteria have been applied because they affect brain structure and function.
- Diagnosis of congestive heart failure
- Diagnosis of atrial fibrillation or other heart arrhythmia
- Diagnosis of Chronic obstructive pulmonary disease
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 |
|---|---|---|
| none, observational studynone, observational study | Other | Cognitively healthy adults, Cognitively impaired adults |
Primary outcome
White matter hyperintensities Volume
Time frame: baseline to year five
White matter lesion volume measured by FLAIR imaging modality
Grey Matter Volume
Time frame: baseline to year five
Grey matter volume measured by T1 imaging modality
Cerebral Blood Flow
Time frame: baseline to year five
Resting cerebral blood flow to brain regions measured by T3 perfusion
Lacunar infarcts
Time frame: baseline to year five
Number of lacunar infarcts measured by MRI
Small vessel microbleeds
Time frame: baseline to year five
Presence and number of microbleeds measured by MRI
Left ventricular ejection fraction
Time frame: baseline to year five
Left ventricular ejection fraction measured by echocardiogram
Cardiac output
Time frame: baseline to year five
Amount of blood the heart pumps from each ventricle per minute, litres per minute (L/min). Measured by echocardiogram
Cardiac stroke volume
Time frame: baseline to year five
Stroke volume measured by echocardiogram
Pulse Wave velocity
Time frame: baseline to year five
pulse wave velocity measured by cardiac MRI
Cardiac Strain
Time frame: baseline to year five
Global longitudinal strain and global circumferential strain measured by cardiac MRI
Biological marker for Alzheimer's disease
Time frame: baseline to year five
Tau, amyloid, neurodegenerative levels measured in cerebrospinal fluid samples
Blood based biological marker for Alzheimer's disease
Time frame: baseline to year five
Tau, amyloid, neurodegenerative levels measured in blood samples
APOE Genotype
Time frame: baseline to year five
APOE e4 allele status
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Aging
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.
Angela Jefferson, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Aging, run by Vanderbilt University Medical Center 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
White matter hyperintensities Volume (time frame: baseline to year five). The study lists 13 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 2026.