Vanderbilt Memory and Aging Project

NCT05372159 | Recruiting

• 10 other identifiers: 120158K23AG045966R01AG034962F32AG046093K24AG046373R01NS100980R01AG056534F32AG058395F31AG066358IIRG-08-8873
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease; Aging; Aged, 80 and Over; Biomarkers; Brain; Case-Control Studies; Cognitive Dysfunction; Neuropsychological Tests

Keywords

Alzheimer's disease; biomarkers; brain MRI; cardiac MRI; mild cognitive impairment; vascular risk factors; longitudinal studies

Outcome Measures

Primary Outcomes (13)

• White matter hyperintensities Volume

  White matter lesion volume measured by FLAIR imaging modality

  baseline to year five

• Grey Matter Volume

  Grey matter volume measured by T1 imaging modality

  baseline to year five

• Cerebral Blood Flow

  Resting cerebral blood flow to brain regions measured by T3 perfusion

  baseline to year five

• Lacunar infarcts

  Number of lacunar infarcts measured by MRI

  baseline to year five

• Small vessel microbleeds

  Presence and number of microbleeds measured by MRI

  baseline to year five

• Left ventricular ejection fraction

  Left ventricular ejection fraction measured by echocardiogram

  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

  baseline to year five

• Cardiac stroke volume

  Stroke volume measured by echocardiogram

  baseline to year five

• Pulse Wave velocity

  pulse wave velocity measured by cardiac MRI

  baseline to year five

• Cardiac Strain

  Global longitudinal strain and global circumferential strain measured by cardiac MRI

  baseline to year five

• Biological marker for Alzheimer's disease

  Tau, amyloid, neurodegenerative levels measured in cerebrospinal fluid samples

  baseline to year five

• Blood based biological marker for Alzheimer's disease

  Tau, amyloid, neurodegenerative levels measured in blood samples

  baseline to year five

• APOE Genotype

  APOE e4 allele status

  baseline to year five

Study Arms (2)

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.

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.

Other: none, observational study

Interventions

none, observational study OTHER

none, observational study

Cognitively healthy adults; Cognitively impaired adults

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community-dwelling older adults.

You may qualify if:

• 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.

You may not qualify if:

• No available reliable study partner
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Aging (NIA): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cerebral spinal fluid, plasma, serum, PAXGene, blood clot.

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Angela Jefferson, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mallory Rockwell

CONTACT

6153228676; mallory.rockwell@vumc.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: May 12, 2022
• Study Start: September 17, 2012
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)