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NCT Number: NCT02605785

A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Sarah M Boland, CCRP

CONTACT

[email protected]

507-284-3863

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

F-18 AV 1451

Drug

Tau PET scan

Other names: Tau binding agent

Primary outcomes

  1. The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.

    Time frame: 5 years

Secondary outcomes

  1. Rates of change in tau-PET burden over time.

    Time frame: baseline, 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah M Boland, CCRP

CONTACT

[email protected]

507-284-3863

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Nov 16, 2015
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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