4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2

Active, not recruiting

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

• Registration Number: NCT02966145
• Lead Sponsor: University of California, San Francisco

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'.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 232

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PSP & CBD	Observational Study	Observational study of participants with a diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration (also called Corticobasal Syndrome or Cortical-basal Ganglionic Degeneration).
o/vPSP	Observational Study	Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome.
Normal Volunteers	Observational Study	Observational study of participants with no known diagnosis of a neurological or neurodegenerative condition, and no known history of memory complaints.

Primary Outcome Measures

Name	Time	Method
Eye Movement Function	Baseline, 6-months, 1-year, and 2-years.	Change from Baseline of eye movement function.
Retinal Imaging	Baseline, 6-months, 1-year, and 2-years.	Change from Baseline of retinal thickness.
Tau-PET Brain Scan	Baseline, 1-year, and 2-years.	Change from Baseline of Tau protein distribution in the brain.
Brain Volume on MRI	Baseline, 6-months, 1-year, and 2-years.	Change from Baseline of brain tissue volume.
UDS Neuropsychological Testing Battery, including supplemental FTLD Module	Baseline, 6-months, 1-year, and 2-years.	Change fromm Baseline of cognitive function.
Amyloid-PET Brain Scan	Baseline	Presence of Amyloid in the brain at Baseline.
Progressive Supranuclear Palsy Rating Scale (PSPRS)	Baseline, 6-months, 1-year, and 2-years.	Change from Baseline of this rating scale.
Corticobasal Degeneration Functional Scale (CBDFS)	Baseline, 6-months, 1-year, and 2-years.	Change from Baseline of this rating scale.

Trial Locations

Locations (8)

University of California, San Diego (UCSD); 🇺🇸 San Diego, California, United States

University of California, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Harvard University - Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States