4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2 (4RTNI-2)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Cortical-basal Ganglionic Degeneration (CBGD); Nonfluent Variant Primary Progressive Aphasia (nfvPPA); Corticobasal Syndrome (CBS); Corticobasal Degeneration (CBD); Oligosymptomatic/Variant Progressive Supranuclear Palsy (o/vPSP); Progressive Supranuclear Palsy (PSP)

Treatments: Other: Observational Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02966145

2R01AG038791-06A1 (U.S. NIH Grant/Contract)

4RTNI-2

Details and patient eligibility

About

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'.

Enrollment: 293 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

293 participants in 3 patient 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).

Treatment:

Other: Observational Study

o/vPSP

Description:

Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome.

Treatment:

Other: Observational Study

Normal Volunteers

Description:

Observational study of participants with no known diagnosis of a neurological or neurodegenerative condition, and no known history of memory complaints.

Treatment:

Other: Observational Study