Recruiting

Alzheimer's Project

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05372172

Conditions

Aging

Alzheimer Disease

Biomarker

Cognitive Dysfunction

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

none, observational study

Study Details

Brief summary:

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.

Conditions

Aging

Alzheimer Disease

Biomarker

Cognitive Dysfunction

Mild Cognitive Impairment

Study ID

NCT05372172

Start date

Oct 27, 2021

Status verified date

Jul, 2025

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cognitively unimpaired

A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.

Mild cognitive impairment

A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.

Alzheimer's disease

A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines.

Interventions

none, observational study

none, observational study

Primary outcome measure

  • Cognitive status [ Time Frame: baseline to year 3 ]
  • APOE Genotype [ Time Frame: baseline to year 3 ]
  • White matter hyperintensities Volume [ Time Frame: baseline to year three ]
  • Grey Matter Volume [ Time Frame: baseline to year three ]
  • Cerebral Blood Flow [ Time Frame: baseline to year three ]
  • Lacunar infarcts [ Time Frame: baseline to year three ]
  • Microbleeds [ Time Frame: baseline to year three ]
  • Left ventricular ejection fraction [ Time Frame: baseline to year three ]
  • Cardiac output [ Time Frame: baseline to year three ]
  • Stroke volume [ Time Frame: baseline to year three ]
  • Heart rate [ Time Frame: baseline to year three ]
  • Biological markers for Alzheimer's disease [ Time Frame: baseline to year three ]
  • Blood based biological marker for Alzheimer's disease [ Time Frame: baseline to year three ]

Central Contacts and Locations

Central contacts

Michelle Houston

615-875-3175michelle.houston@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Jenna Boue

6153228676jenna.boue@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Feb 5, 2026

Last verified

Jul, 2025

Keywords

  • Alzheimer's disease
  • biomarkers
  • brain MRI
  • mild cognitive impairment
  • vascular risk factors
  • longitudinal studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-02-05.