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PET Tau - Neurodegenerative Disease Imaging

ConditionNeurodegenerative Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Pennsylvania

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Positron Emission Tomography (PET/CT) Imaging of Tau Pathology in Neurodegenerative DiseaseExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
10 years

Secondary outcomes

1

Changes over time

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

Time frame
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.

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Avid Radiopharmaceuticals

Collaborator

Source ClinicalTrials.gov
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