PET Tau - Neurodegenerative Disease Imaging

NCT03143374 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 824867
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. This study looks at neurodegenerative diseases such as frontotemporal degeneration (FTD).

Conditions

Neurodegenerative Disease

Keywords

Neurodegenerative Disease

Outcome Measures

Primary Outcomes (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.

  10 years

Secondary Outcomes (2)

• Changes over time

  10 years

• CSF Correlate

  10 years

Study Arms (1)

Positron Emission Tomography (PET/CT) Imaging of Tau Pathology in Neurodegenerative Disease

EXPERIMENTAL

Individuals 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.

Drug: 18F-AV-1451

Interventions

18F-AV-1451 DRUG

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.

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

Positron Emission Tomography (PET/CT) Imaging of Tau Pathology in Neurodegenerative Disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Avid Radiopharmaceuticals: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• David Irwin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dahlia Kamel

CONTACT

215-662-6134; kamel.dahlia@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: May 8, 2017
• Study Start: August 23, 2016
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)