CW2IP2: Imaging and Diagnostic Assessments

Recruiting now · Not applicable

Conditions studied: Tauopathies

In brief

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.

Key facts

Study ID

NCT06083467

Run by

University of Pennsylvania

People needed

94

Starts

2023-07-20

Expected to finish

2028-07-31

Last updated by the study team

2026-01-07

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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..

Where it is running

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

Full record on ClinicalTrials.gov

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