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4 Repeat Tauopathy Neuroimaging Initiative (4RTNI)

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ClinicalTrials.gov Identifier: NCT01804452
Recruitment Status : Active, not recruiting
First Posted : March 5, 2013
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Progressive Supranuclear Palsy Corticobasal Degeneration Other: Observational Study

Study Design
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Study Type : Observational
Actual Enrollment : 110 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Subjects with a diagnosis of PSP or CBD Other: Observational Study


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progressive Supranuclear Palsy Rating Scale [ Time Frame: Baseline, 6 months and 1 year ]
    Change from baseline


Secondary Outcome Measures :
  1. Eye movement function [ Time Frame: Baseline, 6 months and 1 year ]
    Change from baseline

  2. 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.

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Coppola G, Chinnathambi S, Lee JJ, Dombroski BA, Baker MC, Soto-Ortolaza AI, Lee SE, Klein E, Huang AY, Sears R, Lane JR, Karydas AM, Kenet RO, Biernat J, Wang LS, Cotman CW, Decarli CS, Levey AI, Ringman JM, Mendez MF, Chui HC, Le Ber I, Brice A, Lupton MK, Preza E, Lovestone S, Powell J, Graff-Radford N, Petersen RC, Boeve BF, Lippa CF, Bigio EH, Mackenzie I, Finger E, Kertesz A, Caselli RJ, Gearing M, Juncos JL, Ghetti B, Spina S, Bordelon YM, Tourtellotte WW, Frosch MP, Vonsattel JP, Zarow C, Beach TG, Albin RL, Lieberman AP, Lee VM, Trojanowski JQ, Van Deerlin VM, Bird TD, Galasko DR, Masliah E, White CL, Troncoso JC, Hannequin D, Boxer AL, Geschwind MD, Kumar S, Mandelkow EM, Wszolek ZK, Uitti RJ, Dickson DW, Haines JL, Mayeux R, Pericak-Vance MA, Farrer LA; Alzheimer's Disease Genetics Consortium, Ross OA, Rademakers R, Schellenberg GD, Miller BL, Mandelkow E, Geschwind DH. Evidence for a role of the rare p.A152T variant in MAPT in increasing the risk for FTD-spectrum and Alzheimer's diseases. Hum Mol Genet. 2012 Aug 1;21(15):3500-12. doi: 10.1093/hmg/dds161. Epub 2012 May 3.

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 )
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 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