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