4 Repeat Tauopathy Neuroimaging Initiative (4RTNI)

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Summary

  • Study director: Adam Boxer, MD PhD
  • Sponsor: National Institutes of Health (NIH), Tau Research Consortium
  • Recruiting?: No
  • Official study title: 4 Repeat Tauopathy Neuroimaging Initiative (4RTNI)
  • Conditions studied: Corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP)
  • Purpose: The goal of this study is to identify the best methods of analysis for tracking PSP and CBD over time. The results from this study may be used in the future to calculate power for clinical drug trials, as this study aims to identify the most reliable outcome measures. The study will also provide additional information about the relative value of different imaging techniques for diagnosis, and the value of imaging versus other blood, urine, and cerebrospinal fluid (CSF) biomarkers.
  • This study is closed to enrollment. Participants who wish to volunteer for research on corticobasal syndrome (CBS), corticobasal degeneration (CBD) or progressive supranuclear palsy (PSP) should join the second iteration of this study, the 4-Repeat Tauopathy Neuroimaging Initiative – Cycle 2 (4RTNI-2) .

Eligibility

  • Inclusion criteria: Participants must be between the ages of 45 and 90 and meet criteria for progressive supranuclear palsy (PSP) or corticobasal degeneration (CBD). Participants will need a reliable study partner who has frequent contact with the participant, is available to provide information about the participant, and who can accompany the participant to research visits as needed. All participants must be willing and able to undergo testing procedures, including neuroimaging, and agree to longitudinal follow-up.
  • Exclusion criteria: Any significant neurological disease other than PSP or CBD, including Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal pressure hydrocephalus, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities. Any significant systemic illness or unstable medical condition. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. Longstanding (>10 years) history of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed. Longstanding (>10 years) history of major depression, bipolar disorder, or schizophrenia that has had continuous or intermittent symptoms similar to the clinical presentation and requiring medication control up until the time of evaluation. Clinically significant abnormalities in B12, RPR, or TFTs that might interfere with the study.

What is Involved?

  • Testing: Neurological and physical examinations; interview with study partner; MRIs; eye movement testing; cognitive testing; detailed family history; blood and urine specimen collection for cell line generation and biomarker analysis; some but not all participants will undergo lumbar punctures (LP) for CSF specimen collection for biomarker analysis; behavioral testing; questionnaires for participant and study partner. Participants will be asked to participate in additional studies affiliated with this project.
  • Frequency of visits: There will be 1 visit every 6 months for 12 months. Participants will be assessed in Moffitt Hospital in the Clinical & Translational Science Institute (CTSI) Clinical Research Center, as well as at the UCSF Memory and Aging Center, and the UCSF Neuroscience Imaging Center.
  • Materials needed prior to evaluation: None
  • Costs: No costs will be charged for any of the study procedures. Participants will be sent a check for $50 for every MRI scan they undergo, and $100 for every LP.

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