CW2IP2: Imaging and Diagnostic Assessments
ConditionTauopathies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Brain MRI Scan
Diagnostic testMRI scan of the brain
Neurologic exam
BehavioralNeurologic exam and assessments, including video interview
Treatment groups
94 Participants
are divided into 1 treatment groupGroup A: Diagnostic AssessmentsOther 2 interventions
Trial outcomes
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.
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov