Tennessee Alzheimer's Project (TAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction; Dementia; Alzheimer Disease; Aging; Mild Cognitive Impairment; Cognition; Biomarker
• Intervention / Treatment: Other: none, observational study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Michelle Houston; Phone Number: 615-875-3175; Email: michelle.houston@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Jenna Boue; Phone Number: 6153228676; Email: jenna.boue@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Community-dwelling older adults.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cognitively unimpaired; 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
Mild cognitive impairment; 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
Alzheimer's disease; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline to year 3
APOE Genotype	APOE e4 allele status	baseline to year 3
White matter hyperintensities Volume	White matter lesion volume measured by FLAIR imaging modality	baseline to year three
Grey Matter Volume	Grey matter volume measured by T1 imaging modality	baseline to year three
Cerebral Blood Flow	Resting cerebral blood flow to brain regions measured by T3 perfusion	baseline to year three
Lacunar infarcts	Number of lacunar infarcts measured by MRI	baseline to year three
Microbleeds	Number of microbleeds measured by MRI	baseline to year three
Left ventricular ejection fraction	Left ventricular ejection fraction measured by echocardiogram	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	baseline to year three
Stroke volume	Stroke volume measured by echocardiogram	baseline to year three
Heart rate	Heart rate measured by echocardiogram	baseline to year three
Biological markers for Alzheimer's disease	Tau, amyloid, and neurodegenerative levels in cerebrospinal fluid samples	baseline to year three
Blood based biological marker for Alzheimer's disease	Tau, amyloid, and neurodegenerative levels in blood samples	baseline to year three

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Angela Jefferson, PhD, Professor of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: biomarkers; Alzheimer's disease; mild cognitive impairment; brain MRI; vascular risk factors; longitudinal studies
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; Dementia; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 211309; P20AG068082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No