An observational study in Aging, Alzheimer Disease and Biomarker, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Vanderbilt University Medical Center · Observational
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease. The Clinical Core intends to enroll up to 1000 participants, including individuals who are cognitively unimpaired, have mild cognitive impairment, or have Alzheimer's disease. This cohort of about 1000 participants will be called the Tennessee Alzheimer's Project. Participants will be seen annually for comprehensive clinical characterization and then referred to other studies to enhance Alzheimer's disease research activities.
Alzheimer's disease (AD) is a growing public health crisis affecting 5.8 million Americans. With the aging population, AD prevalence is expected to double by 2040. Successful AD prevention and effective therapies require distilling complexities of the disease to better model disease onset, progression, and treatment response. The purpose of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide a better understanding of AD and related dementias, and to serve as the institutional hub of clinical, research, and educational initiatives in AD. The Center will play an essential role in expanding AD discoveries and reducing the burden of AD locally and nationally. To do so, the VADRC will support multiple human studies and model systems research over the coming years. For the Tennessee Alzheimer's Project, the team will establish, phenotype, and annually follow a cohort of adults age 60 and older with and without memory problems. Phenotyping will include standardized protocols implemented across the entire national ADRC network as part of the National Alzheimer's Coordinating Center as well as protocols specific to our local site, including (but not limited to) venous blood draw, questionnaires, physical examination, echocardiogram, neuropsychological assessment, multi-modal neuroimaging, and cerebrospinal fluid acquisition via lumbar puncture. As part of the Center's autopsy program, the investigators will ask all Tennessee Alzheimer's Project participants to consider post-mortem donation of their brain, eyes, and a small skin sample. While fluid and neuroimaging biomarkers exist for some neuropathologies associated with AD and related dementias, postmortem characterization is the only current way to definitively confirm the presence and severity of disease. Locally, a robust tissue bank with excellent ante-mortem phenotyping will provide invaluable tissue for analyses distilling the complexities of AD.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Community-dwelling older adults.
Exclusion Criteria:
A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.
Other: none, observational study
A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.
Other: none, observational study
A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.
Other: none, observational study
none, observational study
Cognitive status
Change in cognitive status assessed by the Uniform Dataset according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines determined by a consensus team.
Time frame: baseline to year 3
APOE Genotype
APOE e4 allele status
Time frame: baseline to year 3
White matter hyperintensities Volume
White matter lesion volume measured by FLAIR imaging modality
Time frame: baseline to year three
Grey Matter Volume
Grey matter volume measured by T1 imaging modality
Time frame: baseline to year three
Cerebral Blood Flow
Resting cerebral blood flow to brain regions measured by T3 perfusion
Time frame: baseline to year three
Lacunar infarcts
Number of lacunar infarcts measured by MRI
Time frame: baseline to year three
Microbleeds
Number of microbleeds measured by MRI
Time frame: baseline to year three
Left ventricular ejection fraction
Left ventricular ejection fraction measured by echocardiogram
Time frame: baseline to year three
Cardiac output
Amount of blood the heart pumps from each ventricle per minute (litres per minute (L/min)), measured by echocardiogram
Time frame: baseline to year three
Stroke volume
Stroke volume measured by echocardiogram
Time frame: baseline to year three
Heart rate
Heart rate measured by echocardiogram
Time frame: baseline to year three
Biological markers for Alzheimer's disease
Tau, amyloid, and neurodegenerative levels in cerebrospinal fluid samples
Time frame: baseline to year three
Blood based biological marker for Alzheimer's disease
Tau, amyloid, and neurodegenerative levels in blood samples
Time frame: baseline to year three
Plan to share: No
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Vanderbilt University Medical Center