Recruiting

Imaging & Diagnostics

Sponsor:

University of Pennsylvania

Code:

NCT06083467

Conditions

Tauopathies

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Brain MRI Scan

Neurologic exam

Study Details

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.

Conditions

Tauopathies

Study ID

NCT06083467

Start date

Jul 20, 2023

Status verified date

Nov, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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..

Study Design

Enrollment

94 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Diagnostic Assessments

Subjects may receive a brain MRI and neurological exam with diagnostic assessments.

Interventions

Brain MRI Scan

MRI scan of the brain

Neurologic exam

Neurologic exam and assessments, including video interview

Primary outcome measure

  • Disease diagnosis [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Erin o Schubert

2155736569erin.schubert@pennmedicine.upenn.edu

Refatun Momo

215-573-6693refatun.momo@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Schubert

215-662-3041erinschu@pennmedicine.upenn.edu

Principal Investigator:

Ilya Nasrallah, MD, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Jan 7, 2026

Last verified

Nov, 2025

Keywords

  • Amyloid PET
  • Movement disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-01-07.