Tennessee Alzheimer's Project

Alzheimer Disease Clinical Trial

— TAP  

Official title:

Tennessee Alzheimer's Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372172
• Other study ID #: 211309
• Secondary ID: P20AG068082
• Status: Recruiting
• Start date: October 27, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Vanderbilt University Medical Center
• Contact: Michelle Houston
• Phone: 615-875-3175
• Email: michelle.houston[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• none, observational study
none, observational study

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	APOE Genotype	APOE e4 allele status	baseline to year 3
Primary	White matter hyperintensities Volume	White matter lesion volume measured by FLAIR imaging modality	baseline to year three
Primary	Grey Matter Volume	Grey matter volume measured by T1 imaging modality	baseline to year three
Primary	Cerebral Blood Flow	Resting cerebral blood flow to brain regions measured by T3 perfusion	baseline to year three
Primary	Lacunar infarcts	Number of lacunar infarcts measured by MRI	baseline to year three
Primary	Microbleeds	Number of microbleeds measured by MRI	baseline to year three
Primary	Left ventricular ejection fraction	Left ventricular ejection fraction measured by echocardiogram	baseline to year three
Primary	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
Primary	Stroke volume	Stroke volume measured by echocardiogram	baseline to year three
Primary	Heart rate	Heart rate measured by echocardiogram	baseline to year three
Primary	Biological markers for Alzheimer's disease	Tau, amyloid, and neurodegenerative levels in cerebrospinal fluid samples	baseline to year three
Primary	Blood based biological marker for Alzheimer's disease	Tau, amyloid, and neurodegenerative levels in blood samples	baseline to year three