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A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02605785
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
120
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: F-18 AV 1451
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tau PET Scan, F-18 AV 1451

All subjects will received a Tau PET scan.

Drug: F-18 AV 1451
Tau PET scan
Other Names:
  • Tau binding agent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The investigators will be looking at the amount of Tau protein in the brain of patients with PSP. [5 years]

    Secondary Outcome Measures

    1. Rates of change in tau-PET burden over time. [baseline, 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Keith Josephs, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Keith A. Josephs, Professor of Neurology, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02605785
    Other Study ID Numbers:
    • 15-004618
    First Posted:
    Nov 16, 2015
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Keith A. Josephs, Professor of Neurology, Mayo Clinic
    PSP
    Additional relevant MeSH terms:
    Supranuclear Palsy, Progressive

    Study Results

    No Results Posted as of Nov 8, 2021