Vanderbilt Memory and Aging Project

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Community-dwelling older adults.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • none, observational study

    Other intervention

    none, observational study

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Cognitively healthy adults1 intervention
Group B: Cognitively impaired adults1 intervention

Trial outcomes

Primary outcomes

1

White matter hyperintensities Volume

White matter lesion volume measured by FLAIR imaging modality

Time frame
baseline to year five
2

Grey Matter Volume

Grey matter volume measured by T1 imaging modality

Time frame
baseline to year five
3

Cerebral Blood Flow

Resting cerebral blood flow to brain regions measured by T3 perfusion

Time frame
baseline to year five
4

Lacunar infarcts

Number of lacunar infarcts measured by MRI

Time frame
baseline to year five

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator