4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2 (4RTNI-2)

April 9, 2025 updated by: University of California, San Francisco

The Four-Repeat Tauopathy Neuroimaging Initiative

The goal of this study is to identify the most reliable methods of analysis for tracking CBD, PSP, and o/vPSP over time. The results from this study may be used in the future to calculate statistical power for clinical drug trials. The study will also provide information about the relative value of novel imaging techniques for diagnosis, as well as the value of imaging techniques versus testing of blood, urine, and cerebrospinal fluid (CSF) 'biomarkers'.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

293

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • University of Toronto
  • United States
    • California
      • San Diego, California, United States, 92037
        • University of California, San Diego (UCSD)
      • San Francisco, California, United States, 94158
        • University of California, San Francisco (UCSF)
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Harvard University - Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants diagnosed with Corticobasal Syndrome (CBS), Corticobasal Degeneration (CBD), Progressive Supranuclear Palsy, or Oligo- or Variant- Progressive Supranuclear Palsy (o/vPSP); Healthy Volunteers.

Description

Inclusion Criteria:

  • No known history of neurological disease, or meet criteria for one of the following: Corticobasal Syndrome or Degeneration (CBS or CBD); Progressive Supranuclear Palsy (PSP); or Oligo- or Variant- Progressive Supranuclear Palsy (o/vPSP)
  • Needs a reliable study partner who has frequent contact with the participant, who is available to provide information about the participant, and who can accompany the participant to research visits as needed
  • Must be willing and able to undergo testing procedures, which include longitudinal follow-up visits
  • Must be able to walk five steps with minimal assistance

Exclusion Criteria:

  • Significant neurological disease other than CBD, PSP, or a variant PSP syndrome.
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal fragments or metal objects in the eyes, skin, or body
  • In the site investigator's opinion, inability to complete sufficient key study procedures, or some other equivalent assessment of impairment

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PSP & CBD
Observational study of participants with a diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration (also called Corticobasal Syndrome or Cortical-basal Ganglionic Degeneration).
Other: Observational Study
o/vPSP
Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome.
Other: Observational Study
Normal Volunteers
Observational study of participants with no known diagnosis of a neurological or neurodegenerative condition, and no known history of memory complaints.
Other: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tau-PET Brain Scan
Time Frame: Baseline, 1-year, and 2-years.
Change from Baseline of Tau protein distribution in the brain.
Baseline, 1-year, and 2-years.
Amyloid-PET Brain Scan
Time Frame: Baseline
Presence of Amyloid in the brain at Baseline.
Baseline
Brain Volume on MRI
Time Frame: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of brain tissue volume.
Baseline, 6-months, 1-year, and 2-years.
Progressive Supranuclear Palsy Rating Scale (PSPRS)
Time Frame: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of this rating scale.
Baseline, 6-months, 1-year, and 2-years.
Corticobasal Degeneration Functional Scale (CBDFS)
Time Frame: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of this rating scale.
Baseline, 6-months, 1-year, and 2-years.
Eye Movement Function
Time Frame: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of eye movement function.
Baseline, 6-months, 1-year, and 2-years.
Retinal Imaging
Time Frame: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of retinal thickness.
Baseline, 6-months, 1-year, and 2-years.
UDS Neuropsychological Testing Battery, including supplemental FTLD Module
Time Frame: Baseline, 6-months, 1-year, and 2-years.
Change fromm Baseline of cognitive function.
Baseline, 6-months, 1-year, and 2-years.

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Adam L Boxer, MD, PhD, University of California, San Francisco

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.

General Publications

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

January 1, 2016

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimated)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4RTNI-2
  • 2R01AG038791-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant data are available by request .

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.

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