NCT06083467 CW2IP2: Imaging and Diagnostic Assessments
| NCT ID | NCT06083467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Tauopathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2023-07-20 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2023-07-20 with a primary completion date of 2028-07-31.
⚠ 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
This current protocol will provide the key data to help determine the specificity of our to-be-developed radiotracers by implementing a multi-site diagnostic assessment core and PET imaging of A-beta amyloid (may be completed at some sites as part of another protocol) that is commonly deposited in the brains of people with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP) or Frontotemporal Dementia (FTD) as well as healthy controls. This multicenter U19 grant is centered at U Pennsylvania (U Penn) (PI: Robert Mach) in collaboration with U Pittsburgh (Pitt), Yale University, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). U Penn will act as the single IRB of Record (sIRB) for this multi-center project and subjects will be recruited from all sites.
Eligibility Criteria
Inclusion Criteria: * Participants: Patients in all cohorts will range from 40 to 85 yrs and will be both male and female. * Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Participants who are deemed unable to provide informed consent must have a designated Legally Authorized Representative(LAR) present for consent and a Study Partner to accompany them to study visits. The LAR and the Study Partner may be the same person. * Clinical diagnoses for each cohort will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP, FTD or Healthy control) Exclusion Criteria: * Females who are pregnant or breast feeding at the time of screening will be excluded * Forms of parkinsonism other than PD, PSP and MSA as defined above * Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) * History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported * Contraindications or Inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician * Implanted medical device or other contraindication to MRI * Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study * Refusal to consent to brain donation (except for HC cohort). All non-HC participants must agree to postmortem brain donation..
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06083467 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Tauopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06083467 currently recruiting?
Yes, NCT06083467 is actively recruiting participants. Contact the research team at erin.schubert@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06083467 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06083467 clinical trial?
NCT06083467 is sponsored by University of Pennsylvania. The trial plans to enroll 94 participants.