Tennessee Alzheimer's Project

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Community-dwelling older adults.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • none, observational study

    Other intervention

    none, observational study

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Cognitively unimpaired1 intervention
Group B: Mild cognitive impairment1 intervention
Group C: Alzheimer's disease1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline to year 3
2

APOE Genotype

APOE e4 allele status

Time frame
baseline to year 3
3

White matter hyperintensities Volume

White matter lesion volume measured by FLAIR imaging modality

Time frame
baseline to year three
4

Grey Matter Volume

Grey matter volume measured by T1 imaging modality

Time frame
baseline to year three

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator