81 Participants Needed

Tau PET Imaging for Frontotemporal Dementia

(SLD3 Trial)

SM
Overseen BySarah M Boland, CCRP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a drug called AV-1451 to study its ability to bind to tau proteins in the brains of patients with PPA and FTD. By doing this, researchers hope to better understand tau buildup in these conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot participate if you are on medications that might affect brain structure or metabolism, like chemotherapy.

Is 18F-flortaucipir (Tauvid) safe for use in humans?

18F-flortaucipir, also known as Tauvid, has been used in various studies for imaging tau protein in the brain, particularly in Alzheimer's disease. While the research primarily focuses on its effectiveness in detecting tau, it has been used safely in humans for these imaging purposes.12345

How is the drug 18F-flortaucipir used in frontotemporal dementia different from other treatments?

18F-flortaucipir is unique because it is a PET imaging agent that specifically targets tau protein deposits in the brain, which are associated with cognitive impairments. Unlike other treatments that may focus on symptoms, this drug helps visualize tau pathology, aiding in the diagnosis and differentiation of frontotemporal dementia from other conditions like Alzheimer's disease.12467

Who Is on the Research Team?

KA

Keith Josephs, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who primarily speak English and have progressive speech/language issues or behavior changes, fitting the criteria for Primary Progressive Aphasia or Frontotemporal Dementia. They need someone to independently assess their functioning but can't join if they have other illnesses causing similar symptoms, are pregnant/breastfeeding, mute/unintelligible speech, MRI contraindications like metal implants, severe claustrophobia, brain structure abnormalities or are on certain medications.

Inclusion Criteria

I am over 18 years old.
I am experiencing worsening problems with my speech, language, or behavior.
I have been diagnosed with Primary Progressive Aphasia or Frontotemporal Dementia.
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Exclusion Criteria

I do not have any illnesses like brain injury or Alzheimer's that affect my speech.
Any subject who is mute or whose speech is unintelligible will be excluded
Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy)
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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 using F-18 AV 1451 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 F-18 AV 1451's ability to detect tau protein in the brain which is linked with Primary Progressive Aphasia and Frontotemporal Dementia. It aims to understand the overall tau burden in patients' brains through PET scans.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Tau PET Scan, F-18 AV 1451Experimental Treatment1 Intervention
All subjects will receive a Tau PET scan.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Published Research Related to This Trial

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.
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]
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.
Tau positron emission tomography imaging in C9orf72 repeat expansion carriers.Ly, CV., Koenig, L., Christensen, J., et al.[2020]
In a study involving 202 participants aged 50 and older, flortaucipir PET imaging revealed a significant increase in tau burden over 18 months in individuals with amyloid-β, indicating a relationship between tau accumulation and cognitive decline in Alzheimer's disease.
The study found that both the initial tau levels and the changes in tau burden were strongly associated with cognitive performance, suggesting that monitoring tau levels could help predict cognitive deterioration in Alzheimer's patients.
A multicentre longitudinal study of flortaucipir (18F) in normal ageing, mild cognitive impairment and Alzheimer's disease dementia.Pontecorvo, MJ., Devous, MD., Kennedy, I., et al.[2022]

Citations

International consensus on the use of tau PET imaging agent 18F-flortaucipir in Alzheimer's disease. [2022]
Tau positron emission tomography imaging in C9orf72 repeat expansion carriers. [2020]
A multicentre longitudinal study of flortaucipir (18F) in normal ageing, mild cognitive impairment and Alzheimer's disease dementia. [2022]
18F-flortaucipir (AV-1451) tau PET in frontotemporal dementia syndromes. [2021]
Head-to-head comparison of tau positron emission tomography tracers [18F]flortaucipir and [18F]RO948. [2021]
Tau PET Imaging with [18F]PM-PBB3 in Frontotemporal Dementia with MAPT Mutation. [2021]
Optimum Differentiation of Frontotemporal Lobar Degeneration from Alzheimer Disease Achieved with Cross-Sectional Tau Positron Emission Tomography. [2023]
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