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Completed

NCT Number: NCT01804452

4 Repeat Tauopathy Neuroimaging Initiative

The purpose of this study is to evaluate several different tests, including brain imaging, eye movement testing, body fluid samples, measurements of memory and other thinking abilities, and measures of functional independence in the hope that this information can be used to guide diagnosis and treatment of PSP and CBD in the future. Recent advances in our understanding of the biological causes of these diseases offer hope for new treatments. As such treatments are developed, sensitive and specific biological measurements (biomarkers) will be needed to provide precise and direct measures of the state of the brain, which will improve the statistical power of clinical trials. Brain imaging with Magnetic Resonance Imaging (MRI) has previously been used to measure disease-related changes in the brain. The goal of this study is to identify the best methods of analysis (including eye movements, imaging, and behavioral measures) for tracking PSP and CBD over time. In addition, certain biomarkers in the blood and cerebrospinal fluid might also be useful for following these diseases over time. This study will examine the value of blood and CSF biomarkers relative to brain imaging and functional measures.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration
  • Must have a reliable study partner who has frequent contact with the subject
  • Willing and able to undergo testing procedures

Exclusion criteria

  • Significant neurological disease other than PSP or CBD
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body

Treatment and study plan

observational study

Other

Primary outcomes

  1. Progressive Supranuclear Palsy Rating Scale

    Time frame: Baseline, 6 months and 1 year

    Change from baseline

Secondary outcomes

  1. Eye movement function

    Time frame: Baseline, 6 months and 1 year

    Change from baseline

  2. Brain volume on MRI

    Time frame: Baseline, 6 months and 1 year

    Change from baseline.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

Observational Longitudinal Study of Magnetic Resonance Imaging, Specimen Biomarkers, and Clinical Progression in Progressive Supranuclear Palsy and Corticobasal Degeneration

Acronym: 4RTNI

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2013
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.