CW2IP2: Imaging and Diagnostic Assessments

Tauopathies Clinical Trial

Official title:

Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Imaging and Diagnostic Assessments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083467
• Other study ID #: 852796
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 20, 2023
• Est. completion date: July 31, 2028

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: Erin o Schubert
• Phone: 2155736569
• Email: erin.schubert[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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. Sites will have local Radiation Research Safety Committee or Radioactive Drug Research Committee oversight over radiation safety related issues specific to the A-beta amyloid radiotracer used at that site (Florbetaben (18F) or 11C-PiB), if the site chooses to include A-beta amyloid PET imaging. Some sites may participate in this diagnostic assessment study without the PET/CT imaging if that data is collected as part of other studies conducted at the site.

The investigators will recruit up to 10 people with PD, 10 healthy controls, 10 with MSA, 10 with PSP and 14 with FTD (4 of these FTD participants are expected tau-negative FTD controls and 10 are expected tau-positive).

Key components of the multi-site diagnostic core will provide the infrastructure for these human imaging studies including regulatory activities (with a sIRB, at Penn); consistency of diagnostic criteria and clinical evaluations (with clinical consensus diagnosis of all participants); common calibration of PET scanners; model consents and protocols; and collection and distribution of clinical and imaging data.

At the sites participating in A-beta amyloid PET/CT as part of this protocol, imaging will be used to evaluate A-beta amyloid deposition in the brain using well established PET A-beta amyloid radiotracers. Each subject will have one positron emission tomography (PET) or PET/computed tomography (PET/CT) scan session. Subjects with a historical positive amyloid PET scan or a negative amyloid PET scan within 2 years may not be required to undergo another scan. Prior scans will be reviewed by an investigator.

Participants who are undergoing A-beta amyloid scan will undergo either approximately 20-30 minutes of static scanning or a 60 minute dynamic scan of the brain depending on the radiotracer selected at the clinical site. The standard uptake time after injection and the dose will vary depending upon which amyloid radiotracer is selected at each site.

Subjects will be required to have a brain MRI performed within 12 months of study enrollment. If the subject has not had a brain MRI that is deemed acceptable for use for this study by an investigator, they will be asked to undergo a research brain MRI after they have consented for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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..

Related Conditions & MeSH terms

• Tauopathies

Intervention

Diagnostic Test:
• Amyloid PET scan
Positron Emission Tomography (PET) scan using either Florbetaben F18 or 11C-PiB radiotracer
• Brain MRI Scan
MRI scan of the brain

Behavioral:
• Neurologic exam
Neurologic exam and assessments, including video interview

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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