AgingTAPNCT05372172
Tennessee Alzheimer's Project
An observational study of Aging and Alzheimer Disease, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Alzheimer Disease, Biomarker
- What is being tested?
- none, observational study
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 31 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling older adults.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jenna Boue, 6153228676, jenna.boue@vumc.org
About this study
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 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.
- Conditions
- Aging, Alzheimer Disease, Biomarker, Cognitive Dysfunction, Mild Cognitive Impairment, Dementia
- Being tested
- none, observational study
- Keywords
- Alzheimer's disease, biomarkers, brain MRI, mild cognitive impairment, vascular risk factors, longitudinal studies
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, observational studyOther
none, observational study
| Study group | Role | What they receive |
|---|---|---|
| Cognitively unimpaired | A consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. Receives: 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. Receives: 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. Receives: Other: none, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to year 3
APOE Genotype
APOE e4 allele status
Measured: baseline to year 3
White matter hyperintensities Volume
White matter lesion volume measured by FLAIR imaging modality
Measured: baseline to year three
Grey Matter Volume
Grey matter volume measured by T1 imaging modality
Measured: baseline to year three
Cerebral Blood Flow
Resting cerebral blood flow to brain regions measured by T3 perfusion
Measured: baseline to year three
Lacunar infarcts
Number of lacunar infarcts measured by MRI
Measured: baseline to year three
Microbleeds
Number of microbleeds measured by MRI
Measured: baseline to year three
Left ventricular ejection fraction
Left ventricular ejection fraction measured by echocardiogram
Measured: baseline to year three
Cardiac output
Amount of blood the heart pumps from each ventricle per minute (litres per minute (L/min)), measured by echocardiogram
Measured: baseline to year three
Stroke volume
Stroke volume measured by echocardiogram
Measured: baseline to year three
Heart rate
Heart rate measured by echocardiogram
Measured: baseline to year three
Biological markers for Alzheimer's disease
Tau, amyloid, and neurodegenerative levels in cerebrospinal fluid samples
Measured: baseline to year three
Blood based biological marker for Alzheimer's disease
Tau, amyloid, and neurodegenerative levels in blood samples
Measured: baseline to year three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start27 Oct 2021
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Angela Jefferson, Vanderbilt University Medical Center
- Investigators
- Angela Jefferson, PhD, Principal investigator, Professor of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372172
- Sponsor's protocol ID
- 211309
- Other IDs
- P20AG068082
- Acronym
- TAP
- Status last verified
- Jul 2025
- First submitted
- 27 Jan 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tennessee Alzheimer's Project
- ClinicalTrials.gov ID
- NCT05372172
- Acronym / sponsor ID
- TAP / 211309
- Conditions
- Aging, Alzheimer Disease, Biomarker, Cognitive Dysfunction, Mild Cognitive Impairment, Dementia
- Keywords
- Alzheimer's disease, biomarkers, brain MRI, mild cognitive impairment, vascular risk factors, longitudinal studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitively unimpaired | – | Other: none, observational studyA consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. |
| Mild cognitive impairment | – | Other: none, observational studyA consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. |
| Alzheimer's disease | – | Other: none, observational studyA consensus team determined cognitive status according to the National Institute on Aging and Alzheimer's Association Workgroup guidelines. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older adults.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none, observational studynone, observational study | Other | Alzheimer's disease, Cognitively unimpaired, Mild cognitive impairment |
Primary outcome
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
Time frame: baseline to year three
White matter lesion volume measured by FLAIR imaging modality
Grey Matter Volume
Time frame: baseline to year three
Grey matter volume measured by T1 imaging modality
Cerebral Blood Flow
Time frame: baseline to year three
Resting cerebral blood flow to brain regions measured by T3 perfusion
Lacunar infarcts
Time frame: baseline to year three
Number of lacunar infarcts measured by MRI
Microbleeds
Time frame: baseline to year three
Number of microbleeds measured by MRI
Left ventricular ejection fraction
Time frame: baseline to year three
Left ventricular ejection fraction measured by echocardiogram
Cardiac output
Time frame: baseline to year three
Amount of blood the heart pumps from each ventricle per minute (litres per minute (L/min)), measured by echocardiogram
Stroke volume
Time frame: baseline to year three
Stroke volume measured by echocardiogram
Heart rate
Time frame: baseline to year three
Heart rate measured by echocardiogram
Biological markers for Alzheimer's disease
Time frame: baseline to year three
Tau, amyloid, and neurodegenerative levels in cerebrospinal fluid samples
Blood based biological marker for Alzheimer's disease
Time frame: baseline to year three
Tau, amyloid, and neurodegenerative levels in blood samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Jefferson, PhD principal investigator
Professor of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Alzheimer Disease, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Houston (615-875-3175, michelle.houston@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive status (time frame: baseline to year 3). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.