TrialPath
← Back to searchRecruiting

Tennessee Alzheimer's Project

NCT05372172 · Vanderbilt University Medical Center
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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.
Eligibility criteria
Inclusion Criteria: * Age 60 or older * Meet standard criteria for (a) cognitively unimpaired, (b) mild cognitive impairment, or (c) Alzheimer's disease * English speaking * Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study Exclusion Criteria: * No available reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person or by phone) * History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness. * Unable to undergo MRI (e.g., claustrophobia, ferrous metal in body)
Study design
Enrollment target: 1000 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-10-27
Estimated completion: 2030-03-31
Last updated: 2026-02-05
Interventions
Other: none, observational study
Primary outcomes
  • Cognitive status (baseline to year 3)
  • APOE Genotype (baseline to year 3)
  • White matter hyperintensities Volume (baseline to year three)
Sponsor
Vanderbilt University Medical Center · other
With: National Institute on Aging (NIA)
Contacts & investigators
ContactMichelle Houston · contact · michelle.houston@vumc.org · 615-875-3175
InvestigatorAngela Jefferson, PhD · principal_investigator, Professor of Neurology
All locations (1)
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Tennessee Alzheimer's Project · TrialPath