A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

November 2, 2023 updated by: Keith A. Josephs, Mayo Clinic
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of change in tau-PET burden over time.
Time Frame: baseline, 1 year
baseline, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Jennifer Whitwell, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimated)

November 16, 2015

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-004618

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Progressive Supranuclear Palsy

Clinical Trials on F-18 AV 1451

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe