NCT03143374 PET Tau - Neurodegenerative Disease Imaging
| NCT ID | NCT03143374 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Pennsylvania |
| Condition | Neurodegenerative Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2016-08-23 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2016-08-23 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
David Irwin, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT03143374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Neurodegenerative Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03143374 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03143374 currently recruiting?
Yes, NCT03143374 is actively recruiting participants. Contact the research team at kamel.dahlia@pennmedicine.upenn.edu for enrollment information.
Where is the NCT03143374 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT03143374 clinical trial?
NCT03143374 is sponsored by University of Pennsylvania. The principal investigator is David Irwin, MD at University of Pennsylvania. The trial plans to enroll 300 participants.