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4 Repeat Tauopathy Neuroimaging Initiative (4RTNI)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01804452
First received: January 18, 2013
Last updated: May 5, 2017
Last verified: May 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Progressive Supranuclear Palsy Corticobasal Degeneration | Other: Observational Study |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Longitudinal Study of Magnetic Resonance Imaging, Specimen Biomarkers, and Clinical Progression in Progressive Supranuclear Palsy and Corticobasal Degeneration |
Resource links provided by NLM:
Genetics Home Reference related topics:
progressive supranuclear palsy
Genetic and Rare Diseases Information Center resources:
Progressive Supranuclear Palsy
Corticobasal Degeneration
Ocular Motility Disorders
Motor Neuro-ophthalmic Disorders
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Progressive Supranuclear Palsy Rating Scale [ Time Frame: Baseline, 6 months and 1 year ]Change from baseline
Secondary Outcome Measures:
- Eye movement function [ Time Frame: Baseline, 6 months and 1 year ]Change from baseline
- Brain volume on MRI [ Time Frame: Baseline, 6 months and 1 year ]Change from baseline.
Biospecimen Retention: Samples With DNA
Plasma, serum, urine, cell lines and cerebrospinal fluid will be retained by study investigators.
| Enrollment: | 110 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Subjects with a diagnosis of PSP or CBD | Other: Observational Study |
Eligibility| Ages Eligible for Study: | 45 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Subjects with a diagnosis of PSP or CBD
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804452
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804452
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94158 | |
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
| Principal Investigator: | Adam Boxer, MD, PhD | University of California, San Francisco |
More Information
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01804452 History of Changes |
| Other Study ID Numbers: |
4RTNI R01AG031278 ( U.S. NIH Grant/Contract ) |
| Study First Received: | January 18, 2013 |
| Last Updated: | May 5, 2017 |
Keywords provided by University of California, San Francisco:
|
Progressive Supranuclear Palsy Corticobasal Degeneration Biomarker Neuroimaging |
MRI Tau Oculomotor |
Additional relevant MeSH terms:
|
Supranuclear Palsy, Progressive Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Ophthalmoplegia Ocular Motility Disorders |
Cranial Nerve Diseases Tauopathies Neurodegenerative Diseases Paralysis Neurologic Manifestations Eye Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 21, 2017