Clinical trial NCT05372172: Tennessee Alzheimer's Project
Official title: Tennessee Alzheimer's Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Alzheimer Disease
Biomarker
Cognitive Dysfunction
Mild Cognitive Impairment
Dementia
Cognition
Keywords: Alzheimer's disease
biomarkers
brain MRI
mild cognitive impairment
vascular risk factors
longitudinal studies
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-05-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community-dwelling older adults.

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cognitive status
timeFrame: baseline to year 3
measure: APOE Genotype
timeFrame: baseline to year 3
measure: White matter hyperintensities Volume
timeFrame: baseline to year three
measure: Grey Matter Volume
timeFrame: baseline to year three
measure: Cerebral Blood Flow
timeFrame: baseline to year three
measure: Lacunar infarcts
timeFrame: baseline to year three
measure: Microbleeds
timeFrame: baseline to year three
measure: Left ventricular ejection fraction
timeFrame: baseline to year three
measure: Cardiac output
timeFrame: baseline to year three
measure: Stroke volume
timeFrame: baseline to year three
measure: Heart rate
timeFrame: baseline to year three
measure: Biological markers for Alzheimer's disease
timeFrame: baseline to year three
measure: Blood based biological marker for Alzheimer's disease
timeFrame: baseline to year three
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Professor of Neurology
name: Angela Jefferson, PhD
role: PRINCIPAL_INVESTIGATOR
References: