RecruitingNCT05372172ClinicalTrials.gov record

Tennessee Alzheimer's Project

Aging · Alzheimer Disease · Biomarker · Cognitive Dysfunction · Mild Cognitive Impairment · Dementia · Cognition

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Observational
Phase: Not applicable / not listed
Age range: 60 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 1000 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 population

Community-dwelling older adults.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

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

none, observational study OTHER

none, observational study

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

APOE Genotype

Time frame: baseline to year 3

APOE e4 allele status

White matter hyperintensities Volume