Recruiting
Phase 2
Phase 3

Neurodegenerative Disease Imaging

Sponsor:

University of Pennsylvania

Code:

NCT03143374

Conditions

Neurodegenerative Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

18F-AV-1451

Study Details

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

Study ID

NCT03143374

Start date

Aug 23, 2016

Status verified date

Oct, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

INCLUSION CRITERIA FOR NEURODEGENERATIVE SUBJECTS

1. 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
2. Participants will be 18 years of age or older
3. 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.
4. Participants must be willing and able to comply with scheduled visits and imaging procedures.
5. Subject is concurrently enrolled in centers UNICORN(842873) protocol.

INCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS

1. Participants will be 18 years of age or older.
2. 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.
3. Participants must be willing and able to comply with scheduled visits and imaging procedures.
4. Subject is concurrently enrolled in centers UNICORN(842873) protocol

EXCLUSION CRITERIA FOR ALL SUBJECTS

1. 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.
2. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
3. Any medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
4. The investigators may choose to exclude participants with clinically significant cardiovascular disease and/or documented abnormalities on ECG out of an abundance of caution.
5. 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

1. 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.
2. Current use of psychoactive medications or substances per medical record review or self-report.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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.

Interventions

18F-AV-1451

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.

Primary outcome measure

  • Regional uptake [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

David Irwin, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Keywords

  • Neurodegenerative Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-10-15.