Observational study on vascular health and Alzheimer's disease in aging adults
Vanderbilt Memory and Aging Project
Vanderbilt University Medical Center · NCT05372159
This study looks at how the health of blood vessels affects brain function and structure in adults over 50, especially in relation to early signs of Alzheimer's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05372159 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to explore the relationship between vascular health and various clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among adults aged 50 and older. The study will assess both cross-sectional and longitudinal data, adjusting for relevant clinical factors, to test the hypothesis that vascular health impacts cognitive function and brain structure before significant cognitive decline occurs. Additionally, it will investigate medical and genetic factors that may mediate these associations, including inflammatory processes and genetic risk factors like APOE. The findings are expected to enhance understanding of how vascular health influences brain aging.
Who should consider this trial
Good fit: Ideal candidates include adults aged 50 and older, with a focus on those with mild cognitive impairment or those who are cognitively unimpaired.
Not a fit: Patients with a history of major psychiatric or neurological illnesses, or those with significant head injuries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for early detection and intervention in Alzheimer's disease and related cognitive decline.
How similar studies have performed: Previous studies have shown promising results in understanding the relationship between cardiovascular health and cognitive decline, suggesting that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Angela Jefferson, PhD — Vanderbilt University Medical Center
- Study coordinator: Mallory Rockwell
- Email: mallory.rockwell@vumc.org
- Phone: 6153228676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease, Aging, Aged, 80 and Over, Biomarkers, Brain, Case-Control Studies, Cognitive Dysfunction, Neuropsychological Tests