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Completed

NCT Number: NCT02966145

4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2

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'.

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Key information

Conditions

Corticobasal Degeneration (CBD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cortical-basal Ganglionic Degeneration (CBGD) Corticobasal Degeneration Corticobasal Syndrome (CBS) Cranial Nerve Diseases Dementia Eye Diseases Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nonfluent Variant Primary Progressive Aphasia (nfvPPA) Ocular Motility Disorders Oligosymptomatic/Variant Progressive Supranuclear Palsy (o/vPSP) Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Pick Disease of the Brain Progressive Supranuclear Palsy (PSP) Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Toronto, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

Primary outcomes

  1. Tau-PET Brain Scan

    Time frame: Baseline, 1-year, and 2-years.

    Change from Baseline of Tau protein distribution in the brain.

  2. Amyloid-PET Brain Scan

    Time frame: Baseline

    Presence of Amyloid in the brain at Baseline.

  3. Brain Volume on MRI

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

    Change from Baseline of brain tissue volume.

  4. Progressive Supranuclear Palsy Rating Scale (PSPRS)

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

    Change from Baseline of this rating scale.

  5. Corticobasal Degeneration Functional Scale (CBDFS)

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

    Change from Baseline of this rating scale.

  6. Eye Movement Function

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

    Change from Baseline of eye movement function.

  7. Retinal Imaging

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

    Change from Baseline of retinal thickness.

  8. UDS Neuropsychological Testing Battery, including supplemental FTLD Module

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

    Change fromm Baseline of cognitive function.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

The Four-Repeat Tauopathy Neuroimaging Initiative

Acronym: 4RTNI-2

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2016
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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