Tennessee Alzheimer's Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-27

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aging Alzheimer Disease Biomarker Cognitive Dysfunction Mild Cognitive Impairment Dementia Cognition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cognitively unimpaired

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

none, observational study

Intervention Type 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.

none, observational study

Intervention Type 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.

none, observational study

Intervention Type OTHER

none, observational study

Interventions

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none, observational study

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes