CW2IP2: Imaging and Diagnostic Assessments
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.
Conditions:
🦠 Tauopathies
🗓️ Study Start (Actual) 20 July 2023
🗓️ Primary Completion (Estimated) 31 July 2028
✅ Study Completion (Estimated) 31 July 2028
👥 Enrollment (Estimated) 54
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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..
Ages Eligible for Study: 40 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 July 2023
  • First Submitted that Met QC Criteria 10 October 2023
  • First Posted 16 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 October 2023
  • Last Update Posted 17 October 2023
  • Last Verified October 2023