Imaging and diagnostic assessments for tauopathies
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Imaging and Diagnostic Assessments
This study is testing new brain imaging tools to see if they can help identify different types of brain diseases in people with Parkinson's and other related conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06083467 on ClinicalTrials.gov |
What this trial studies
This protocol aims to gather critical data to evaluate the specificity of newly developed radiotracers through a multi-site diagnostic assessment core. It involves PET imaging of A-beta amyloid in individuals with Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Frontotemporal Dementia, and healthy controls. The study is a multicenter initiative led by the University of Pennsylvania, collaborating with several prestigious institutions. Participants will undergo brain MRI scans and neurologic exams as part of the assessment.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40 to 85 with a clinical diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Frontotemporal Dementia, or healthy controls.
Not a fit: Patients with forms of parkinsonism other than PD, PSP, and MSA, as well as those with major psychiatric disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for tauopathies, leading to better-targeted treatments for patients.
How similar studies have performed: Other studies utilizing similar imaging techniques have shown promise in improving diagnostic capabilities for neurodegenerative diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
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..
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Erin o Schubert
- Email: erin.schubert@pennmedicine.upenn.edu
- Phone: 2155736569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.