A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

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Brief Title

A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

Official Title

A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

Brief Summary

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



Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Rates of change in tau-PET burden over time.

Condition

Progressive Supranuclear Palsy

Intervention

F-18 AV 1451

Study Arms / Comparison Groups

 Tau PET Scan, F-18 AV 1451
Description:  All subjects will received a Tau PET scan.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

November 2015

Completion Date

November 2025

Primary Completion Date

November 2025

Eligibility Criteria

        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.
      

Gender

All

Ages

35 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Keith Josephs, MD, 507-284-3863, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02605785

Organization ID

15-004618


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

Keith Josephs, MD, Principal Investigator, Mayo Clinic


Verification Date

November 2021