Alzheimer Disease Clinical Trial
— VMAPOfficial title:
Vanderbilt Memory and Aging Project
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | White matter hyperintensities Volume | White matter lesion volume measured by FLAIR imaging modality | baseline to year five | |
Primary | Grey Matter Volume | Grey matter volume measured by T1 imaging modality | baseline to year five | |
Primary | Cerebral Blood Flow | Resting cerebral blood flow to brain regions measured by T3 perfusion | baseline to year five | |
Primary | Lacunar infarcts | Number of lacunar infarcts measured by MRI | baseline to year five | |
Primary | Small vessel microbleeds | Presence and number of microbleeds measured by MRI | baseline to year five | |
Primary | Left ventricular ejection fraction | Left ventricular ejection fraction measured by echocardiogram | baseline to year five | |
Primary | 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 | |
Primary | Cardiac stroke volume | Stroke volume measured by echocardiogram | baseline to year five | |
Primary | Pulse Wave velocity | pulse wave velocity measured by cardiac MRI | baseline to year five | |
Primary | Cardiac Strain | Global longitudinal strain and global circumferential strain measured by cardiac MRI | baseline to year five | |
Primary | Biological marker for Alzheimer's disease | Tau, amyloid, neurodegenerative levels measured in cerebrospinal fluid samples | baseline to year five | |
Primary | Blood based biological marker for Alzheimer's disease | Tau, amyloid, neurodegenerative levels measured in blood samples | baseline to year five | |
Primary | APOE Genotype | APOE e4 allele status | baseline to year five |
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