A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

Last updated: November 7, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Progressive Supranuclear Palsy

Treatment

F-18 AV 1451

Clinical Study ID

NCT02605785
15-004618
  • Ages > 35
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be over 35 years of age and present with gradual progression of PSP-relatedsymtoms

  • Must have an informant or study partner that can provide independent information offunctioning.

  • Must meet criteria for possible or probable Progressive Supranuclear Palsy. Tofulfill criteria for possible PSP, subjects must have a gradually progressivedisorder with either vertical (upward or downward) supranuclear palsy or bothslowing of vertical saccades and prominent postural instability with falls in thefirst year of disease onset. To fulfill criteria for probable PSP, subjects musthave vertical (upward or downward gaze) supranuclear palsy and prominent posturalinstability with falls in the first year of disease onset.

Exclusion

Exclusion Criteria:

  • Subjects will be excluded if they meet criteria for another neurodegenerativedisease (including corticobasal syndrome, frontotemporal dementia, primaryprogressive aphasia, Alzheimer's disease, multiple system atrophy and Parkinson'sdisease) or do not have the symptoms necessary to fulfill inclusion criteria forpossible PSP.

  • Subjects with concurrent illnesses that could account for their symptoms, such astraumatic brain injury, encephalitis, strokes or developmental syndromes will beexcluded.

  • 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 geneticconditions 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, cardiacpace maker, e.t.c.), if there is severe claustrophobia, if there are conditions thatmay confound brain imaging studies (e.g. structural abnormalities, includingsubdural hematoma, intracranial neoplasm or large cortical infarcts), or if they aremedically unstable or are on medications that might affect brain structure ormetabolism (e.g. chemotherapy).

  • Subjects will also be excluded if they do not have an informant, or do not consentto research.

Study Design

Total Participants: 332
Treatment Group(s): 1
Primary Treatment: F-18 AV 1451
Phase:
Study Start date:
November 01, 2015
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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