Imaging tau protein in the brain for neurodegenerative diseases

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

This study is testing a new brain imaging method to see if it can help detect tau protein levels in people with memory and thinking problems linked to diseases like Alzheimer's.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Pennsylvania (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT03143374 on ClinicalTrials.gov

What this trial studies

This study aims to measure the levels of tau protein in the brain using Positron Emission Tomography (PET/CT) imaging. Tau accumulation is associated with various neurodegenerative diseases, including Alzheimer's and frontotemporal degeneration. Researchers will utilize a specialized radioactive tracer, 18F-AV-1451, to visualize tau binding in patients experiencing cognitive and memory issues. The study will compare PET/CT results with other diagnostic methods such as MRI and cognitive tests to assess the accuracy and utility of this imaging technique for future diagnoses.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with neurodegenerative diseases such as Alzheimer's, frontotemporal degeneration, or Parkinson's disease.

Not a fit: Patients without a diagnosis of neurodegenerative diseases or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance diagnostic accuracy for neurodegenerative diseases, leading to better patient management.

How similar studies have performed: Other studies using PET imaging for tau protein have shown promise, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: David Irwin, MD — University of Pennsylvania
• Study coordinator: Dahlia Kamel

Conditions: Neurodegenerative Disease