4 Repeat Tauopathy Neuroimaging Initiative (4RTNI)
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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 |
- Progressive Supranuclear Palsy Rating Scale [ Time Frame: Baseline, 6 months and 1 year ] [ Designated as safety issue: No ]Change from baseline
- Eye movement function [ Time Frame: Baseline, 6 months and 1 year ] [ Designated as safety issue: No ]Change from baseline
- Brain volume on MRI [ Time Frame: Baseline, 6 months and 1 year ] [ Designated as safety issue: No ]Change from baseline.
Biospecimen Retention: Samples With DNA
Plasma, serum, urine, cell lines and cerebrospinal fluid will be retained by study investigators.
| Estimated Enrollment: | 110 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects with a diagnosis of PSP or CBD
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01804452
| Contact: Dan N Luong, BS | 415-476-9578 | PLuong@memory.ucsf.edu |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94158 | |
| Contact: Dan Luong 415-476-9578 PLuong@memory.ucsf.edu | |
| Principal Investigator: Adam L Boxer, MD, PhD | |
More Information
Additional Information:
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01804452 History of Changes |
| Other Study ID Numbers: | 4RTNI, R01AG031278 |
| Study First Received: | January 18, 2013 |
| Last Updated: | January 13, 2015 |
| Health Authority: | United States: Institutional Review Board |
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 Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases |
Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Signs and Symptoms Tauopathies |
ClinicalTrials.gov processed this record on February 27, 2015