Clinical trial NCT02966145: 4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2
Official title: The Four-Repeat Tauopathy Neuroimaging Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corticobasal Degeneration (CBD)
Corticobasal Syndrome (CBS)
Cortical-basal Ganglionic Degeneration (CBGD)
Progressive Supranuclear Palsy (PSP)
Nonfluent Variant Primary Progressive Aphasia (nfvPPA)
Oligosymptomatic/Variant Progressive Supranuclear Palsy (o/vPSP)
Keywords: CBD
CBS
CBGD
PSP
nfvPPA
oPSP
vPSP
o/vPSP
Corticobasal Degeneration
Corticobasal Syndrome
Cortocal-basal Ganglionic Degeneration
Progressive Supranuclear Palsy
Nonfluent Variant Primary Progressive Aphasia
Oligosymptomatic Progressive Supranuclear Palsy
Variant Progressive Supranuclear Palsy
Biomarker
Neuroimaging
MRI
PET
Tau
Oculomotor
Retinal Imaging
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2016-11-17
Enrollment: 293
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed with Corticobasal Syndrome (CBS), Corticobasal Degeneration (CBD), Progressive Supranuclear Palsy, or Oligo- or Variant- Progressive Supranuclear Palsy (o/vPSP); Healthy Volunteers.

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'.


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

Primary outcomes:
measure: Tau-PET Brain Scan
timeFrame: Baseline, 1-year, and 2-years.
measure: Amyloid-PET Brain Scan
timeFrame: Baseline
measure: Brain Volume on MRI
timeFrame: Baseline, 6-months, 1-year, and 2-years.
measure: Progressive Supranuclear Palsy Rating Scale (PSPRS)
timeFrame: Baseline, 6-months, 1-year, and 2-years.
measure: Corticobasal Degeneration Functional Scale (CBDFS)
timeFrame: Baseline, 6-months, 1-year, and 2-years.
measure: Eye Movement Function
timeFrame: Baseline, 6-months, 1-year, and 2-years.
measure: Retinal Imaging
timeFrame: Baseline, 6-months, 1-year, and 2-years.
measure: UDS Neuropsychological Testing Battery, including supplemental FTLD Module
timeFrame: Baseline, 6-months, 1-year, and 2-years.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego (UCSD)
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Charlestown
country: United States
facility: Harvard University - Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of California, San Francisco
name: Adam L Boxer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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