Tau PET Imaging for Alzheimer's Disease

(ABCD2-TAU Trial)

LA
DA
Overseen ByDavid A Wolk, MD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain brain changes might relate to aging and the early stages of Alzheimer's Disease. It involves a PET scan, an imaging test, to study brain health in older adults. The trial uses [18F]AV-1451, also known as (18F)Flortaucipir, a radiotracer used in these scans. It specifically targets African American individuals aged 65 and older who are part of an ongoing study and show normal cognitive function. Participants will have already undergone specific brain scans and assessments. By understanding these brain patterns, researchers aim to unlock clues about cognitive decline. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on brain health and aging.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this PET/CT method is safe for cognitively normal older adults?

Studies have shown that [18F]AV-1451, also known as Flortaucipir, is generally safe for use in PET scans. Research indicates that this tracer effectively identifies tau protein build-up in the brain, aiding in the study of Alzheimer's disease.

One study found a potential risk, as the tracer affected a heart safety test. However, the safety margin is 42 times higher than the risky level, indicating a very low actual risk.

The FDA has already approved Flortaucipir for certain PET scans, supporting its safety record. So far, significant reports of serious side effects in humans have not emerged. Overall, Flortaucipir is considered well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about [18F]AV-1451, also known as Flortaucipir, because it offers a new way to visualize tau proteins in the brain using PET/CT imaging. Unlike current treatments for neurodegenerative conditions, which often focus on symptomatic relief, Flortaucipir allows doctors to directly observe tau pathology, which is a hallmark of diseases like Alzheimer's. This imaging could lead to earlier and more accurate diagnoses, potentially transforming how these conditions are managed and treated.

What evidence suggests that this PET/CT method is effective for studying age-related cognitive decline and preclinical Alzheimer's Disease?

Research shows that [18F]Flortaucipir is a promising tool for imaging tau proteins in the brain. Tau proteins can accumulate in conditions like Alzheimer's disease, and early detection aids in understanding memory and thinking problems. Studies have shown that [18F]Flortaucipir accurately identifies these tau deposits. This tracer is recognized for its high accuracy in assessing Alzheimer's and other brain conditions. It enables doctors to observe and track changes in the brain, offering insights into early-stage memory and thinking issues before symptoms emerge.678910

Who Is on the Research Team?

DA

David A Wolk, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Inclusion Criteria

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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo a one-day PET scan using the radiotracer [18F]AV-1451

1 day
1 visit (in-person)

Follow-up

Participants are monitored annually as part of the ABCD2 study

4 years
Annual visits

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]AV-1451
  • (18F)Flortaucipir

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: PET/CTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Pennsylvania Department of Health

Collaborator

Trials
42
Recruited
999,000+

Citations

Article Improved interpretation of 18 F-florzolotau PET in ...

We developed a normalization-free deep-learning (NFDL) model for 18 F-florzolotau PET, which achieved significantly higher accuracy for both PSP and MSA-P.

Direct Comparison of the Tau PET Tracers 18F-Flortaucipir ...

This study compared 2 frequently used tau PET tracers, 18F-flortaucipir and 18F-MK-6240, in the same subjects. Methods: 18F-flortaucipir and 18F-MK-6240 scans ...

Development and Validation of a 18F-Flortaucipir PET Visual ...

We developed a novel 18 F-flortaucipir PET (FTP, or Tauvid) visual read method enabling stratification of patients with Alzheimer disease (AD) according to the ...

QC Data for Process Verification Batches of [ 18 F]AV1451

In conclusion, [18F]Flortaucipir was reproducibly achieved with desired radiochemical yield and high radiochemical purity and molar activity. Three GMP ...

Parametric Estimation of Reference Signal Intensity for ...

In this study, we evaluated the utility and reliability of the PERSI method for analyzing data from PET imaging using 2 different tau tracers— ...

18F-Flortaucipir (AV1451) imaging identifies grey matter ...

This study aimed (1) to assess the association of imaging evidence of tau pathology with brain volumes in retired athletes and (2) to examine ...

Flortaucipir (18F)

Flortaucipir (18 F), sold under the brand name Tauvid, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging to ...

Tauvid™: The First FDA-Approved PET Tracer for Imaging ...

Tauvid might have a potential cardiotoxicity as it had an IC50 value of 0.610 μM in the in vitro hERG assay. Nevertheless, the safety margin is at least 42-fold ...

Discriminative Accuracy of [ 18 F]flortaucipir Positron ...

The use of [ 18 F]flortaucipir PET had an estimated sensitivity of 89.9% and specificity of 90.6% for Alzheimer disease vs other neurodegenerative diseases.

An updated radiosynthesis of [ 18 F]AV1451 for tau PET imaging

[18F]AV1451 is a commonly used radiotracer for imaging tau deposits in Alzheimer's disease (AD) and related non-AD tauopathies.