4-Repeat Tauopathy Neuroimaging Initiative – Cycle 2

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Brief Title

4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2

Official Title

The Four-Repeat Tauopathy Neuroimaging Initiative

Brief Summary

      The goal of this study is to identify the most reliable methods of analysis for tracking CBD,
      PSP, and o/vPSP over time. The results from this study may be used in the future to calculate
      statistical power for clinical drug trials. The study will also provide information about the
      relative value of novel imaging techniques for diagnosis, as well as the value of imaging
      techniques versus testing of blood, urine, and cerebrospinal fluid (CSF) 'biomarkers'.
    



Study Type

Observational


Primary Outcome

Tau-PET Brain Scan


Condition

Corticobasal Degeneration (CBD)

Intervention

Observational Study

Study Arms / Comparison Groups

 PSP & CBD
Description:  Observational study of participants with a diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration (also called Corticobasal Syndrome or Cortical-basal Ganglionic Degeneration).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

232

Start Date

January 2016

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

          -  No known history of neurological disease, or meet criteria for one of the following:
             Corticobasal Syndrome or Degeneration (CBS or CBD); Progressive Supranuclear Palsy
             (PSP); or Oligo- or Variant- Progressive Supranuclear Palsy (o/vPSP)

          -  Needs a reliable study partner who has frequent contact with the participant, who is
             available to provide information about the participant, and who can accompany the
             participant to research visits as needed

          -  Must be willing and able to undergo testing procedures, which include longitudinal
             follow-up visits

          -  Must be able to walk five steps with minimal assistance

        Exclusion Criteria:

          -  Significant neurological disease other than CBD, PSP, or a variant PSP syndrome.

          -  Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or
             metal fragments or metal objects in the eyes, skin, or body

          -  In the site investigator's opinion, inability to complete sufficient key study
             procedures, or some other equivalent assessment of impairment
      

Gender

All

Ages

40 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Adam L Boxer, MD, PhD, (415) 476-0668, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02966145

Organization ID

4RTNI-2

Secondary IDs

2R01AG038791-06A1

Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Adam L Boxer, MD, PhD, Principal Investigator, University of California, San Francisco


Verification Date

May 2021