Progressive Supranuclear PalsyNCT02605785
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
A study testing F-18 AV 1451 in people with Progressive Supranuclear Palsy, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP). Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- F-18 AV 1451
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Sarah M Boland, CCRP, 507-284-3863, boland.sarah@mayo.edu
About this study
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- F-18 AV 1451
- Keywords
- PSP
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 AV 1451Drug
Also called Tau binding agent
Tau PET scan
| Study group | Role | What they receive |
|---|---|---|
| Tau PET Scan, F-18 AV 1451 | Experimental | All subjects will received a Tau PET scan. Receives: Drug: F-18 AV 1451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
Measured: 5 years
Secondary outcomes (1)
Rates of change in tau-PET burden over time.
Measured: baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith A. Josephs, Mayo Clinic
- Investigators
- Jennifer Whitwell, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605785
- Sponsor's protocol ID
- 15-004618
- Other IDs
- R01NS089757
- Status last verified
- Apr 2026
- First submitted
- 3 Nov 2015
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT02605785
- Acronym / sponsor ID
- 15-004618
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- PSP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 2015
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tau PET Scan, F-18 AV 1451 | Experimental | Drug: F-18 AV 1451All subjects will received a Tau PET scan. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18 AV 1451Also: Tau binding agentTau PET scan | Drug | Tau PET Scan, F-18 AV 1451 |
Primary outcome
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
Time frame: 5 years
1 secondary outcome
Rates of change in tau-PET burden over time.
Time frame: baseline, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Whitwell, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-18 AV 1451 in people with Progressive Supranuclear Palsy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah M Boland, CCRP (507-284-3863, boland.sarah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.