Overview

This trial is active, not recruiting.

Conditions progressive supranuclear palsy, corticobasal degeneration
Treatment observational study
Sponsor University of California, San Francisco
Collaborator National Institutes of Health (NIH)
Start date January 2011
End date March 2017
Trial size 110 participants
Trial identifier NCT01804452, 4RTNI, R01AG031278

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
observational study

Primary Outcomes

Measure
Progressive Supranuclear Palsy Rating Scale
time frame: Baseline, 6 months and 1 year

Secondary Outcomes

Measure
Eye movement function
time frame: Baseline, 6 months and 1 year
Brain volume on MRI
time frame: Baseline, 6 months and 1 year

Eligibility Criteria

Male or female participants from 45 years up to 90 years old.

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

Additional Information

Official title Observational Longitudinal Study of Magnetic Resonance Imaging, Specimen Biomarkers, and Clinical Progression in Progressive Supranuclear Palsy and Corticobasal Degeneration
Principal investigator Adam Boxer, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.