NCT05372172

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Oct 2021Mar 2030

Study Start

First participant enrolled

October 27, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

February 5, 2026

Status Verified

July 1, 2025

Enrollment Period

8.4 years

First QC Date

January 27, 2022

Last Update Submit

February 2, 2026

Conditions

Keywords

Alzheimer's diseasebiomarkersbrain MRImild cognitive impairmentvascular risk factorslongitudinal studies

Outcome Measures

Primary Outcomes (13)

  • 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

Study Arms (3)

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

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

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

Interventions

none, observational study

Alzheimer's diseaseCognitively unimpairedMild cognitive impairment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-dwelling older adults.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cerebral spinal fluid, plasma, serum, PAXGene, blood clot.

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementia

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Angela Jefferson, PhD

    Professor of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

January 27, 2022

First Posted

May 12, 2022

Study Start

October 27, 2021

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

February 5, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations