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CW2IP2: Imaging and Diagnostic Assessments

Primary Purpose

Tauopathies

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amyloid PET scan
Brain MRI Scan
Neurologic exam
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tauopathies focused on measuring Amyloid PET, Movement disorders

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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..

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic Assessments

Arm Description

Subjects may receive an Amyloid PET scan, a brain MRI and neurological exam with diagnostic assessments.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
October 14, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT06083467
Brief Title
CW2IP2: Imaging and Diagnostic Assessments
Official Title
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Imaging and Diagnostic Assessments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
July 31, 2028 (Anticipated)
Study Completion Date
July 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tauopathies
Keywords
Amyloid PET, Movement disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Assessments
Arm Type
Other
Arm Description
Subjects may receive an Amyloid PET scan, a brain MRI and neurological exam with diagnostic assessments.
Intervention Type
Diagnostic Test
Intervention Name(s)
Amyloid PET scan
Intervention Description
Positron Emission Tomography (PET) scan using either Florbetaben F18 or 11C-PiB radiotracer
Intervention Type
Diagnostic Test
Intervention Name(s)
Brain MRI Scan
Intervention Description
MRI scan of the brain
Intervention Type
Behavioral
Intervention Name(s)
Neurologic exam
Intervention Description
Neurologic exam and assessments, including video interview
Primary Outcome Measure Information:
Title
Disease diagnosis
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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..
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin o Schubert
Phone
2155736569
Email
erin.schubert@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Refatun Momo
Phone
215-573-6693
Email
refatun.momo@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Schubert
Phone
215-662-3041
Email
erinschu@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Ilya Nasrallah, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A request to utilize de-identified data will be reviewed by the Clinical Core Oversight Committee (CCOC). Each investigator using data is required to sign a Use Agreement form that stipulates the following: Data received will only be used for the purposes stated in the study design. Received data will not be distributed to others (apart from collaborators named in the study). The investigator will not attempt to directly or indirectly identify participants. Results will be made available to the research community in a timely manner and acknowledge CW2IP2.
IPD Sharing Time Frame
Screening data including neurologic assessments, brain MRI and Amyloid PET results shared when collected. Clinical study report after completion of the study.

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CW2IP2: Imaging and Diagnostic Assessments

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