4 Repeat Tauopathy Neuroimaging Initiative (4RTNI)

January 22, 2024 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

110

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
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • John Hopkins University

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

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects with a diagnosis of PSP or CBD

Description

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

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
Subjects with a diagnosis of PSP or CBD
Other: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive Supranuclear Palsy Rating Scale
Time Frame: Baseline, 6 months and 1 year
Change from baseline
Baseline, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye movement function
Time Frame: Baseline, 6 months and 1 year
Change from baseline
Baseline, 6 months and 1 year
Brain volume on MRI
Time Frame: Baseline, 6 months and 1 year
Change from baseline.
Baseline, 6 months and 1 year

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 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, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimated)

March 5, 2013

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4RTNI
  • R01AG031278 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Corticobasal Degeneration

Clinical Trials on Observational Study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe