CW2IP2: Imaging and Diagnostic Assessments

NCT06083467 | Recruiting

• 1 other identifier: 852796
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Keywords

Amyloid PET; Movement disorders

Outcome Measures

Primary Outcomes (1)

• Disease diagnosis

  The primary outcome is a diagnosis classification of a neurodegenerative disease. Participants will be referred based on a clinical evaluation suggesting possible Parkinson Disease, Progressive Supranuclear Palsy, Multiple System Atrophy, Frontotemporal Lobar Degeneration, or other neurodegenerative disease or as a likely healthy control. Participants will have cognitive testing, physical examination, imaging studies, and record review, which will be used to determine the probable diagnosis. If no probable diagnosis is achieved, the outcome would be an uncertain diagnosis.

  8 weeks

Study Arms (1)

Diagnostic Assessments

OTHER

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

Diagnostic Test: Brain MRI Scan; Behavioral: Neurologic exam

Interventions

Brain MRI Scan DIAGNOSTIC_TEST

MRI scan of the brain

Diagnostic Assessments

Neurologic exam BEHAVIORAL

Neurologic exam and assessments, including video interview

Diagnostic Assessments

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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..

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Tauopathies; Movement Disorders

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Central Nervous System Diseases

Central Study Contacts

Erin o Schubert

CONTACT

2155736569; erin.schubert@pennmedicine.upenn.edu

Refatun Momo

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: October 16, 2023
• Study Start: July 20, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Screening data including neurologic assessments, brain MRI and Amyloid PET results shared when collected. Clinical study report after completion of the study.

Locations

US (1)