4 Repeat Tauopathy Neuroimaging Initiative

Active, not recruiting

• Conditions: Progressive Supranuclear Palsy; Corticobasal Degeneration
• Interventions: Other: Observational Study

• Registration Number: NCT01804452
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-05
• Study Start: 2014-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with a diagnosis of PSP or CBD	Observational Study	-

Primary Outcome Measures

Name	Time	Method
Progressive Supranuclear Palsy Rating Scale	Baseline, 6 months and 1 year	Change from baseline

Secondary Outcome Measures

Name	Time	Method
Brain volume on MRI	Baseline, 6 months and 1 year	Change from baseline.
Eye movement function	Baseline, 6 months and 1 year	Change from baseline

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States