Status:
RECRUITING
CW2IP2: Imaging and Diagnostic Assessments
Lead Sponsor:
University of Pennsylvania
Conditions:
Tauopathies
Eligibility:
All Genders
40-85 years
Phase:
NA
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 ...
Detailed Description
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 to be compared with new ra...
Eligibility Criteria
Inclusion
- 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
- 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..
Key Trial Info
Start Date :
July 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06083467
Start Date
July 20 2023
End Date
July 31 2028
Last Update
January 7 2026
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104