4 Repeat Tauopathy Neuroimaging Initiative (4RTNI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01804452
First received: January 18, 2013
Last updated: June 25, 2014
Last verified: June 2014
  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:


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 ] [ Designated as safety issue: No ]
    Change from baseline


Secondary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: August 2015 (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
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

Contacts
Contact: Dan N Luong, BS 415-476-9578 PLuong@memory.ucsf.edu

Locations
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         
Sponsors and Collaborators
University of California, San Francisco
  More Information

Additional 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
Study First Received: January 18, 2013
Last Updated: June 25, 2014
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
Paralysis
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014