A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

NCT ID: NCT02605785

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2025-11-30

Brief Summary

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

Detailed Description

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Conditions

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Progressive Supranuclear Palsy

Keywords

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PSP

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tau PET Scan, F-18 AV 1451

All subjects will received a Tau PET scan.

Group Type EXPERIMENTAL

F-18 AV 1451

Intervention Type DRUG

Tau PET scan

Interventions

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F-18 AV 1451

Tau PET scan

Intervention Type DRUG

Other Intervention Names

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Tau binding agent

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Keith A. Josephs

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Whitwell, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah M Boland, CCRP

Role: CONTACT

Phone: 507-284-3863

Email: [email protected]

Facility Contacts

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Sarah M Boland, CCRP

Role: primary

Related Links

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Other Identifiers

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15-004618

Identifier Type: -

Identifier Source: org_study_id