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Neurodegenerative DiseasePhase 2/3NCT03143374

PET Tau - Neurodegenerative Disease Imaging

A Phase 2/3 study testing 18F-AV-1451 in people with Neurodegenerative Disease, run by University of Pennsylvania at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown to build up in the brains of patients with injury to brain cells. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Neurodegenerative Disease
What is being tested?
18F-AV-1451
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
23 Aug 2016to Sep 2030
Phase
Phase 2/3
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 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants has been diagnosed with one of the following neurodegenerative diseases: FTD, PPA, CBD, PSP, MCI, AD, PCA, PD, PDD, DLB, MSA, ALS or FTD- ALS
  • Participants will be 18 years of age or older
  • Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the subject is unable to provide informed consent, the subject's legal representative may consent on behalf of the patient, but the patient will be asked to confirm assent.
  • Participants must be willing and able to comply with scheduled visits and imaging procedures.
  • Subject is concurrently enrolled in centers UNICORN(842873) protocol.
  • Participants will be 18 years of age or older.
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  • Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
  • Participants must be willing and able to comply with scheduled visits and imaging procedures.
  • Subject is concurrently enrolled in centers UNICORN(842873) protocol

Who cannot join

  • Females who are pregnant or breast feeding at the time of the baseline PET/CT scan will not be eligible for this study. A urine pregnancy test will be performed in women of child-bearing potential at screening and within 24 hours of any scheduled PET/CT.
  • Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
  • Any medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
  • The investigators may choose to exclude participants with clinically significant cardiovascular disease and/or documented abnormalities on ECG out of an abundance of caution.
  • The investigators of UNICORN (IRB #842873) have determined the participant has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan.
  • ADDITIONAL EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS
  • Pre-existing psychiatric conditions (e.g., active depression, schizophrenia, or active anxiety) or neurological conditions (e.g., stroke, epilepsy, head trauma) per medical record review or self-report.
  • Current use of psychoactive medications or substances per medical record review or self-report.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dahlia Kamel contact

215-662-6134

kamel.dahlia@pennmedicine.upenn.edu

United States1 site, 1 recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Dahlia Kamel, 215-662-6134, kamel.dahlia@pennmedicine.upenn.edu

    David Irwin, MD

    Recruiting

Other trials in United States

About this study

Official title: Positron Emission Tomography (PET) Imaging of Tau Pathology in Neurodegenerative Disease

The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown to build up in the brains of patients with injury to brain cells. This study looks at neurodegenerative diseases such as frontotemporal degeneration (FTD).

Read the detailed description

The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown to build up in the brains of patients with injury to brain cells, including Alzheimer's disease, Parkinson's disease, Lewy body disease and Frontotemporal degeneration. 18F-AV-1451 (formally known as 18F-T807) is a specialized radioactive PET tracer that sticks to the tau protein in the brain. In this study, researchers will use 18F-AV-1451 to form images of tau binding in the brain. 18F-AV-1451 is an investigational or experimental imaging agent that has not yet been approved by the Food and Drug Administration for use in brain imaging.

In this study, researchers want to find out how accurate and useful 18F-AV-1451 is in imaging patients who have problems with thinking, remembering, speech, and visual activities, and may be diagnosed with different types of neurodegenerative disease. This study will help test how imaging measures may provide information that could be used to determine diagnosis for patients in the future. The results of the PET/CT scan will be compared with other information obtained under related protocols, including brain magnetic resonance imaging (MRI), spinal fluid and cognitive test results.

Being tested
18F-AV-1451
Keywords
Neurodegenerative Disease
Medical subject headings
Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-AV-1451Drug

    Also called formally known as 18F-T807, 7-(6-[18F]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole

    The experimental tracer used for this study is called 18F-AV-1451 is a specialized radioactive PET tracer used to detect the presence of tau proteins in the brain.

    Participants will undergo a baseline 18F-AV-1451 brain scan. If funding is available, participants will be asked to return for one or more longitudinal visits, including a 18F-AV-1451 brain scan, every 9 to 18 months after the prior visit.

    The 18F-AV-1451 PET/CT scan will require up to 3 hours of time, including preparation. The scan will take place using PET/CT scanners in the Perelman Center for Advanced Medicine or the Hospital of the University of Pennsylvania.

Study groups in NCT03143374
Study groupRoleWhat they receive
Positron Emission Tomography (PET/CT) Imaging of Tau Pathology in Neurodegenerative DiseaseExperimentalIndividuals who have been diagnosed with FTD, PPA, CBD, PSP, MCI, AD, PCA, PD, PDD, DLB, MSA, ALS or FTD-ALS may participate in this study if they are 18 years of age or older; most participants will be receiving care at the clinical practices of the of the University of Pennsylvania and at Pennsylvania Hospital Department of Neurology. Healthy control subjects will also be recruited for this study.
Receives: Drug: 18F-AV-1451

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regional uptake

    Examine regional anatomic distribution of PET-tau uptake comparatively in dementia syndromes and PET-Tau uptake with neuropsychology and MRI regional GM atrophy at baseline collected under other center protocols. Uptake with neuropsychology and MRI regional GM atrophy at baseline.

    Measured: 10 years

Secondary outcomes (2)

  1. Changes over time

    Use regression to relate longitudinal neuropsychological and regional MRI decline in dementia syndromes to baseline regional PET-tau uptake.

    Measured: 10 years

  2. CSF Correlate

    Correlate CSF total and phosphorylated (p-tau/t-tau) tau with regional PET-tau uptake in dementia syndromes at baseline.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study start23 Aug 2016
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03143374
Sponsor's protocol ID
824867
Status last verified
Oct 2026
First submitted
2 Nov 2016
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 18F-AV-1451 in people with Neurodegenerative 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 9 inclusion and 8 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 16 Oct 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Dahlia Kamel (215-662-6134, kamel.dahlia@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional uptake (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03143374.

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 16 Oct 2026.

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