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NCT Number: NCT05372172

Tennessee Alzheimer's Project

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.

Recruiting

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Key information

Conditions

Aging Alzheimer Disease Biomarker Brain Diseases Central Nervous System Diseases Cognition Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Jenna Boue

CONTACT

[email protected]

6153228676

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

none, observational study

Other

none, observational study

Primary outcomes

  1. Cognitive status

    Time frame: baseline to year 3

    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.

  2. APOE Genotype

    Time frame: baseline to year 3

    APOE e4 allele status

  3. White matter hyperintensities Volume

    Time frame: baseline to year three

    White matter lesion volume measured by FLAIR imaging modality

  4. Grey Matter Volume

    Time frame: baseline to year three

    Grey matter volume measured by T1 imaging modality

  5. Cerebral Blood Flow

    Time frame: baseline to year three

    Resting cerebral blood flow to brain regions measured by T3 perfusion

  6. Lacunar infarcts

    Time frame: baseline to year three

    Number of lacunar infarcts measured by MRI

  7. Microbleeds

    Time frame: baseline to year three

    Number of microbleeds measured by MRI

  8. Left ventricular ejection fraction

    Time frame: baseline to year three

    Left ventricular ejection fraction measured by echocardiogram

  9. Cardiac output

    Time frame: baseline to year three

    Amount of blood the heart pumps from each ventricle per minute (litres per minute (L/min)), measured by echocardiogram

  10. Stroke volume

    Time frame: baseline to year three

    Stroke volume measured by echocardiogram

  11. Heart rate

    Time frame: baseline to year three

    Heart rate measured by echocardiogram

  12. Biological markers for Alzheimer's disease

    Time frame: baseline to year three

    Tau, amyloid, and neurodegenerative levels in cerebrospinal fluid samples

  13. Blood based biological marker for Alzheimer's disease

    Time frame: baseline to year three

    Tau, amyloid, and neurodegenerative levels in blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Houston

CONTACT

[email protected]

615-875-3175

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: TAP

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
May 12, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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