An interventional study of Brain MRI Scan and Neurologic exam in Tauopathies, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Diagnostic
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.
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 to be compared with new radiotracer scans for 4RTau and Alphasynuclein which are compounds 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.
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.
75 studies on the registry are indexed under Tauopathies; 18 are open to participants now.
This study's planned enrollment of 94 is above the median of 72 across 54 interventional studies indexed under Tauopathies.
Browse Tauopathies studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects may receive a brain MRI and neurological exam with diagnostic assessments.
Diagnostic Test: Brain MRI Scan · Behavioral: Neurologic exam
MRI scan of the brain
Neurologic exam and assessments, including video interview
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 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Screening data including neurologic assessments, brain MRI and Amyloid PET results shared when collected. Clinical study report after completion of the study.
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Jul 2028, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.