Cognitive DeclineABCD2-TAUNCT05393388
Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study
An observational study of Cognitive Decline and Alzheimer Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
We will conduct a Tau PET scan in cognitively normal older adults, enrolled in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-Tau) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).Study duration will generally be a one-day study visit for PET imaging… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Alzheimer Disease
- What is being tested?
- [18F]AV-1451
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to May 2027
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Study population includes cognitively normal, older adult (>65 years old) black or African American participants
Who may be able to join
- Males and females African Americans ≥ 65 years of age.
- Part of the ABCD2 longitudinal cohort, protocol 844047, of the PMC/ADCC with consensus conference designation of normal cognition.
- ABCD2 longitudinal visit must be completed or scheduled to be completed within 1 year prior to the [18F]AV-1451 TAU PET scan.
- A brain MRI must be performed within 1 year prior to their study [18F]AV-1451 TAU PET scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.
- An amyloid PET scan completed or scheduled within 1year of their study [18F]AV-1451
- Women must be post-menopausal or surgically sterile.
Who cannot join
- Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, including major depression and prior head trauma.
- Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan.
- Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
- Have a history of significant ongoing alcohol or substance abuse or dependence based on self-report.
- Women of child bearing potential
- The inclusion / exclusion criteria will be ascertained through self-report in conjunction with any medical history available through the participant's medical or research records (EPIC or the ADC database)*
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania - Penn Memory Center
Philadelphia, Pennsylvania, 19104
About this study
We will conduct a Tau PET scan in cognitively normal older adults, enrolled in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-Tau) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).Study duration will generally be a one-day study visit for PET imaging, but all subjects will be followed annually as part of their participation in the ABCD2 study. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of preclinical Alzheimer's Disease.
- Conditions
- Cognitive Decline, Alzheimer Disease
- Being tested
- [18F]AV-1451
- Keywords
- Healthy Subjects
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]AV-1451Drug
Also called [F-18]T807
[18F]AV-1451 has been developed as a positron emitting radiopharmaceutical for in vivo imaging of tau protein aggregates.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT | PET.CT using the radiotracer [18F]AV-1451 Receives: Drug: [18F]AV-1451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of [18F]AV-1451 in the medial temporal lobe
A quantitative measurement of [18F]AV-1451(standardized value uptake ratio - SUVR) within the medial temporal lobe (MTL).from PET/CT
Measured: 4 years
Volume of medial temporal lobe subregion
A quantitative measurement of volume (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.
Measured: 4 years
Thickness of medial temporal lobe subregion
A quantitative measurement of thickness (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start6 Jul 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- David A Wolk, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393388
- Sponsor's protocol ID
- 844403
- Acronym
- ABCD2-TAU
- Status last verified
- Nov 2025
- First submitted
- 16 May 2022
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study
- ClinicalTrials.gov ID
- NCT05393388
- Acronym / sponsor ID
- ABCD2-TAU / 844403
- Conditions
- Cognitive Decline, Alzheimer Disease
- Keywords
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 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.
We will conduct a Tau PET scan in cognitively normal older adults, enrolled in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-Tau) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).Study duration will generally be a one-day study visit for PET imaging, but all subjects will be followed annually as part of their participation in the ABCD2 study. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of preclinical Alzheimer's Disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT | – | Drug: [18F]AV-1451PET.CT using the radiotracer [18F]AV-1451 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Study population includes cognitively normal, older adult (>65 years old) black or African American participants
Key inclusion criteria (6 listed)
- Males and females African Americans ≥ 65 years of age.
- Part of the ABCD2 longitudinal cohort, protocol 844047, of the PMC/ADCC with consensus conference designation of normal cognition.
- ABCD2 longitudinal visit must be completed or scheduled to be completed within 1 year prior to the [18F]AV-1451 TAU PET scan.
- A brain MRI must be performed within 1 year prior to their study [18F]AV-1451 TAU PET scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.
- An amyloid PET scan completed or scheduled within 1year of their study [18F]AV-1451
Key exclusion criteria (6 listed)
- Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, including major depression and prior head trauma.
- Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan.
- Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
- Have a history of significant ongoing alcohol or substance abuse or dependence based on self-report.
- Women of child bearing potential
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 |
|---|---|---|
| [18F]AV-1451Also: [F-18]T807[18F]AV-1451 has been developed as a positron emitting radiopharmaceutical for in vivo imaging of tau protein aggregates. | Drug | PET/CT |
Primary outcome
Uptake of [18F]AV-1451 in the medial temporal lobe
Time frame: 4 years
A quantitative measurement of [18F]AV-1451(standardized value uptake ratio - SUVR) within the medial temporal lobe (MTL).from PET/CT
Volume of medial temporal lobe subregion
Time frame: 4 years
A quantitative measurement of volume (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.
Thickness of medial temporal lobe subregion
Time frame: 4 years
A quantitative measurement of thickness (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.
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 26 Nov 2025.
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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. This study is not recruiting at the moment.
David A Wolk, MD principal investigator
University of Pennsylvania
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 Cognitive Decline and Alzheimer Disease, run by University of Pennsylvania 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of [18F]AV-1451 in the medial temporal lobe (time frame: 4 years). The study lists 3 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 26 Nov 2025.