Tau Imaging with F-18 AV 1451 for Progressive Supranuclear Palsy

Overseen By Sarah M Boland, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy

Disqualifiers: Alzheimer's, Parkinson's, Strokes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

332 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about the amount of tau protein in the brains of people with Progressive Supranuclear Palsy (PSP), a condition that affects movement and balance. Participants will undergo a special type of brain scan using F-18 AV 1451 (also known as Tauvid or Flortaucipir F-18) to measure tau levels. This study suits individuals over 35 who have experienced a gradual worsening of PSP symptoms, such as trouble with eye movements or frequent falls. As an unphased trial, it offers participants the opportunity to contribute to a deeper understanding of PSP and its effects.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you may be excluded if you are on medications that might affect brain structure or metabolism, like chemotherapy.

What prior data suggests that the F-18 AV 1451 imaging technique is safe for patients with Progressive Supranuclear Palsy?

Research shows that F-18 AV 1451, also known as Flortaucipir F-18 or Tauvid, is used in PET scans to examine tau proteins in the brain. This aids in understanding diseases like Alzheimer's and Progressive Supranuclear Palsy (PSP).

Studies have found that F-18 AV 1451 is generally safe for people. The FDA has approved it for use in Alzheimer's patients, indicating its safety for brain imaging. However, its safety and effectiveness for other conditions, such as chronic traumatic encephalopathy, remain uncertain.

Overall, current evidence supports the safe use of F-18 AV 1451 in brain imaging for studying diseases related to tau proteins. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tau PET scan with F-18 AV 1451 for Progressive Supranuclear Palsy because it offers a new way to visualize tau protein deposits in the brain, which are key indicators of the disease. Unlike traditional treatments that mainly focus on managing symptoms, this technique aims to provide a clearer picture of disease progression. By accurately mapping tau accumulation, it could lead to earlier and more precise diagnoses, potentially guiding more effective treatment strategies in the future.

What evidence suggests that this imaging technique is effective for assessing tau burden in Progressive Supranuclear Palsy?

Research shows that F-18 AV 1451, also known as Tauvid, effectively visualizes tau proteins in the brain. It is primarily used to study Alzheimer's disease. This tracer attaches to tau lesions, which are unusual protein buildups in the brain. In this trial, all participants will receive a Tau PET scan using F-18 AV 1451 to explore its use for Progressive Supranuclear Palsy (PSP). While its application for PSP remains under investigation, the FDA has approved F-18 AV 1451 for imaging tau in other conditions, suggesting it might help researchers understand tau-related changes in PSP. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer Whitwell, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 35 with Progressive Supranuclear Palsy (PSP) symptoms and a diagnosis of possible or probable PSP. Participants need an informant to provide additional information about their functioning. Exclusions include pregnancy, other neurodegenerative diseases, conditions that mimic PSP symptoms, certain genetic conditions increasing cancer risk, contraindications to MRI, severe claustrophobia, and unstable medical conditions.

Inclusion Criteria

Must have an informant or study partner that can provide independent information of functioning

I am over 35 and my PSP symptoms are getting worse slowly.

I have been diagnosed with Progressive Supranuclear Palsy.

Exclusion Criteria

I do not have any other neurodegenerative diseases besides possible PSP.

I do not have genetic conditions like Cowden, Lynch syndrome, or Down's syndrome.

I do not have illnesses like brain injury, encephalitis, strokes, or developmental syndromes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a Tau PET scan to assess tau burden in the brain

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• F-18 AV 1451

Trial Overview

The study tests the imaging agent F-18 AV 1451 to measure tau protein accumulation in the brain of patients with PSP. It aims to understand the overall burden of tau in these patients using advanced imaging techniques.

How Is the Trial Designed?

Group I: Tau PET Scan, F-18 AV 1451 Experimental Treatment 1 Intervention

All subjects will received a Tau PET scan.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

C9orf72 expansion carriers showed increased tau accumulation in the entorhinal cortex as measured by AV-1451 PET imaging, indicating a potential link to primary age-related tauopathy.

Despite the increased tau uptake, there was no correlation between AV-1451 accumulation and clinical severity, disease duration, or cognitive performance in the studied individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tau positron emission tomography imaging in C9orf72 repeat expansion carriers. Ly, CV., Koenig, L., Christensen, J., et al.[2020]

In a study involving 33 patients with progressive supranuclear palsy (PSP), 18 F-flortaucipir showed significantly elevated uptake in specific brain regions compared to normal controls (46 participants) and patients with Parkinson disease (26 participants), indicating its potential as a biomarker for tau pathology in PSP.

The globus pallidus region was particularly effective in distinguishing PSP patients from both controls and Parkinson disease patients, with high accuracy (AUC values of 0.872 and 0.893, respectively), suggesting that 18 F-flortaucipir could aid in the diagnosis of PSP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18 F-flortaucipir tau positron emission tomography distinguishes established progressive supranuclear palsy from controls and Parkinson disease: A multicenter study. Schonhaut, DR., McMillan, CT., Spina, S., et al.[2022]

In a study involving 10 patients with progressive supranuclear palsy (PSP) and 60 controls, the [18 F]AV-1451 PET ligand showed elevated signals in specific brain regions associated with PSP, indicating its potential for in vivo assessment of tau pathology in this condition.

The regional distribution of [18 F]AV-1451 uptake in PSP was distinct from that in Alzheimer's dementia, with higher signals in the pallidum and midbrain for PSP, while Alzheimer's showed greater cortical signals, suggesting different underlying tau pathology in these diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18 F]AV-1451 tau positron emission tomography in progressive supranuclear palsy. Whitwell, JL., Lowe, VJ., Tosakulwong, N., et al.[2022]

In a study involving 14 patients with progressive supranuclear palsy (PSP), 18F-AV-1451 PET imaging revealed distinct subcortical binding patterns indicative of tau pathology, particularly in areas like the putamen and globus pallidus, compared to healthy controls.

However, the study found no correlation between the levels of 18F-AV-1451 binding and the severity of motor dysfunction in PSP patients, suggesting that this imaging technique may not be ideal for assessing tau pathology in relation to clinical symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcortical 18 F-AV-1451 binding patterns in progressive supranuclear palsy. Cho, H., Choi, JY., Hwang, MS., et al.[2022]

The FDA-approved radiotracer 18F-flortaucipir is increasingly used in PET imaging to visualize tau pathology in patients with cognitive impairment, particularly Alzheimer's disease.

An international consensus has been established to standardize the procedural use of 18F-flortaucipir PET imaging, which will enhance its application in clinical practice for diagnosing and managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International consensus on the use of tau PET imaging agent 18F-flortaucipir in Alzheimer's disease. Tian, M., Civelek, AC., Carrio, I., et al.[2022]

The radiation dose from the PET radioligand [(18)F]AV-1451 was estimated to be 4.7 mSv for a standard injection of 185 MBq, indicating a manageable level of exposure for healthy subjects.

The liver was identified as the critical organ for radiation burden, but the overall effective dose suggests that multiple PET scans using [(18)F]AV-1451 could be safely performed within a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Radiation Dosimetry of [(18)F]AV-1451(T807) to Detect Tau Pathology. Choi, JY., Lyoo, CH., Lee, JH., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02167594

Tau Imaging in Subjects With Progressive Supranuclear ...

18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4900162/

Validating novel tau PET tracer [F-18]-AV-1451 (T807) on ...

Our data suggest that AV-1451 strongly binds to tau lesions primarily made of paired helical filaments in Alzheimer's brains e.g. intra and extraneuronal ...

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jnm.snmjournals.org

jnm.snmjournals.org/content/63/7/1052

In Vivo 18 F-Flortaucipir PET Does Not Accurately Support the ...

We used a data-driven approach to test whether postmortem pathologic staging in PSP can be reproduced in vivo with 18 F-flortaucipir PET.

4.

withpower.com

withpower.com/trial/phase-supranuclear-palsy-progressive-10-2015-e2917

Tau Imaging with F-18 AV 1451 for Progressive ...

F-18 AV 1451, also known as Tauvid or Flortaucipir F-18, has been used in PET imaging to study tau protein in the brain, primarily for Alzheimer's disease.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7911942/

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

Tauvid is also known as [18F]Flortaucipir, [18F]AV-1451, and [18F]T807. Its IUPAC name is 7-(6-[18F]fluoropyridine-3-yl)-5H-pyrido [4,3-b]indole. The ...

6.

go.drugbank.com

go.drugbank.com/drugs/DB14914

Flortaucipir F-18: Uses, Interactions, Mechanism of Action

The safety and efficacy of flortaucipir F-18 in patients being evaluated for chronic traumatic encephalopathy are unknown and hence is not recommended.