ClinicalTrials.gov record NCT02605785
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This diagnostic study uses a Tau PET scan (F-18 AV-1451) to measure tau protein in people with possible or probable Progressive Supranuclear Palsy (PSP). Participants receive PET imaging at baseline and some will have follow-up imaging to look for change over time. The study is designed to learn about overall tau burden and how it changes.
What it is studying. The study is testing how much tau protein can be detected in the brains of people with PSP using the radioactive tracer F-18 AV-1451 on PET scans, and it is measuring changes in that tau signal over time.
What the researchers hope to learn. To measure the amount of tau protein in PSP brains; to describe rates of change in tau PET signals over time; to map tau distribution in PSP for research purposes.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- F-18 AV 1451
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Must be over 35 years of age and present with gradual progression of PSP-related symtoms
- Must have an informant or study partner that can provide independent information of functioning.
- Must meet criteria for possible or probable Progressive Supranuclear Palsy. To fulfill criteria for possible PSP, subjects must have a gradually progressive disorder with either vertical (upward or downward) supranuclear palsy or both slowing of vertical saccades and prominent postural instability with falls in the first year of disease onset. To fulfill criteria for probable PSP, subjects must have vertical (upward or downward gaze) supranuclear palsy and prominent postural instability with falls in the first year of disease onset.
Exclusion criteria
- Subjects will be excluded if they meet criteria for another neurodegenerative disease (including corticobasal syndrome, frontotemporal dementia, primary progressive aphasia, Alzheimer's disease, multiple system atrophy and Parkinson's disease) or do not have the symptoms necessary to fulfill inclusion criteria for possible PSP.
- Subjects with concurrent illnesses that could account for their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes will be excluded.
- Women that are pregnant or post-partum and breast-feeding will be excluded.
- Subjects will be excluded from the study if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome.
- Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts), or if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy).
- Subjects will also be excluded if they do not have an informant, or do not consent to research.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will undergo a Tau PET brain scan using the tracer F-18 AV 1451 to measure tau protein in the brain. Imaging is planned at baseline and at about 1 year to assess change over time. You must bring an informant/study partner who can provide independent information, give informed consent, and complete medical screening to confirm eligibility and imaging safety. The study may include other noninvasive checks as needed to ensure imaging can be done safely.
How the study is structured. Interventional diagnostic imaging study in a single group: all participants receive an F-18 AV-1451 Tau PET scan. There is no randomization or masking; scans are done at baseline and some participants have at least one follow-up scan to compare change.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on progressive supranuclear palsy
Important dates
- Study start
- November 2015
- Primary completion
- January 2030 (estimated)
- Study completion
- January 2030 (estimated)
- Target enrollment
- 332 participants (estimated)
- Last updated on registry
- May 5, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Mayo Clinic
- Principal investigator
- Keith A. Josephs, Professor of Neurology
Mayo Clinic - Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Sarah M Boland, CCRP 📞 507-284-3863 ✉ boland.sarah@mayo.edu
Participating sites (1)
- Mayo ClinicRecruiting
Rochester, Minnesota, 55905 · United States
- Sarah M Boland, CCRP · 507-284-3863 · boland.sarah@mayo.edu
Terms used on this page · explanations by MedicalUpdates.ai
- inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- contraindicated
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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