CompletedNot Applicable

4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2

United States293 participantsStarted 2016-01

Plain-language 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'.

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Tau-PET Brain Scan

Timeframe: Baseline, 1-year, and 2-years.

Amyloid-PET Brain Scan

Timeframe: Baseline

Brain Volume on MRI

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Progressive Supranuclear Palsy Rating Scale (PSPRS)

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Corticobasal Degeneration Functional Scale (CBDFS)

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Eye Movement Function

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Retinal Imaging

Timeframe: Baseline, 6-months, 1-year, and 2-years.

UDS Neuropsychological Testing Battery, including supplemental FTLD Module

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Trial details

NCT IDNCT02966145

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-28

View on ClinicalTrials.gov More Corticobasal Degeneration (CBD) trials

Plain-language summary

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Tau-PET Brain Scan

Timeframe: Baseline, 1-year, and 2-years.

Amyloid-PET Brain Scan

Timeframe: Baseline

Brain Volume on MRI

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Progressive Supranuclear Palsy Rating Scale (PSPRS)

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Corticobasal Degeneration Functional Scale (CBDFS)

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Eye Movement Function

Timeframe: Baseline, 6-months, 1-year, and 2-years.

Retinal Imaging

Timeframe: Baseline, 6-months, 1-year, and 2-years.

UDS Neuropsychological Testing Battery, including supplemental FTLD Module

Timeframe: Baseline, 6-months, 1-year, and 2-years.