4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2 (4RTNI-2)
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ClinicalTrials.gov Identifier: NCT02966145 |
Recruitment Status :
Recruiting
First Posted : November 17, 2016
Last Update Posted : May 20, 2021
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Condition or disease | Intervention/treatment |
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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) | Other: Observational Study |
Study Type : | Observational |
Estimated Enrollment : | 232 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Four-Repeat Tauopathy Neuroimaging Initiative |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

Group/Cohort | Intervention/treatment |
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PSP & CBD
Observational study of participants with a diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration (also called Corticobasal Syndrome or Cortical-basal Ganglionic Degeneration).
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Other: Observational Study |
o/vPSP
Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome.
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Other: Observational Study |
Normal Volunteers
Observational study of participants with no known diagnosis of a neurological or neurodegenerative condition, and no known history of memory complaints.
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Other: Observational Study |
- Tau-PET Brain Scan [ Time Frame: Baseline, 1-year, and 2-years. ]Change from Baseline of Tau protein distribution in the brain.
- Amyloid-PET Brain Scan [ Time Frame: Baseline ]Presence of Amyloid in the brain at Baseline.
- Brain Volume on MRI [ Time Frame: Baseline, 6-months, 1-year, and 2-years. ]Change from Baseline of brain tissue volume.
- Progressive Supranuclear Palsy Rating Scale (PSPRS) [ Time Frame: Baseline, 6-months, 1-year, and 2-years. ]Change from Baseline of this rating scale.
- Corticobasal Degeneration Functional Scale (CBDFS) [ Time Frame: Baseline, 6-months, 1-year, and 2-years. ]Change from Baseline of this rating scale.
- Eye Movement Function [ Time Frame: Baseline, 6-months, 1-year, and 2-years. ]Change from Baseline of eye movement function.
- Retinal Imaging [ Time Frame: Baseline, 6-months, 1-year, and 2-years. ]Change from Baseline of retinal thickness.
- UDS Neuropsychological Testing Battery, including supplemental FTLD Module [ Time Frame: Baseline, 6-months, 1-year, and 2-years. ]Change fromm Baseline of cognitive function.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966145
Contact: Adam Boxer, MD, Phd | (415) 476-0668 | adam.boxer@ucsf.edu | |
Contact: Hilary Heuer, PhD | (415) 476-6743 | Hilary.Heuer@ucsf.edu |
United States, California | |
University of California, San Diego (UCSD) | Recruiting |
San Diego, California, United States, 92037 | |
Contact: Ileana Rubio 858-822-5751 irubio@ucsd.edu | |
Principal Investigator: Irene Litvan, MD | |
University of California, San Francisco (UCSF) | Recruiting |
San Francisco, California, United States, 94158 | |
Contact: Stephanie Vento, BS 415-476-8333 Stephanie.Vento@ucsf.edu | |
Contact: Hilary Heuer, PhD (415) 476-6743 Hilary.Heuer@ucsf.edu | |
Principal Investigator: Adam Boxer, MD,PhD | |
Principal Investigator: Lawren VandeVrede, MD,PhD | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Diane Lanham 443-287-4156 Dlanham1@jhmi.edu | |
Principal Investigator: Alex Pantelyat, MD | |
United States, Massachusetts | |
Harvard University - Massachusetts General Hospital | Recruiting |
Charlestown, Massachusetts, United States, 02129 | |
Contact: Samantha Krivensky, BA 617-726-6205 SKrivensky@mgh.harvard.edu | |
Principal Investigator: Bradford C Dickerson, MD | |
United States, Minnesota | |
Mayo Clinic - Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Ruth Kraft 507-538-9487 Kraft.Ruth@mayo.edu | |
Principal Investigator: Bradley F Boeve, MD | |
United States, New York | |
Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Masood Manoochehri 212-305-1818 mm2626@cumc.columbia.edu | |
Principal Investigator: Edward Huey, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Dahlia Kamel 215-662-6134 mailto:kamel.dahlia@pennmedicine.upenn.edu | |
Principal Investigator: Murray Grossman, MD | |
Sub-Investigator: David Irwin, MD | |
Canada, Ontario | |
University of Toronto | Recruiting |
Toronto, Ontario, Canada, M5T 2S8 | |
Contact: Cristina Salvo Cristina.Salvo@uhn.ca | |
Principal Investigator: Maria Carmela Tartaglia, MD, FRCPC |
Principal Investigator: | Adam L Boxer, MD, PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02966145 |
Other Study ID Numbers: |
4RTNI-2 2R01AG038791-06A1 ( U.S. NIH Grant/Contract ) |
First Posted: | November 17, 2016 Key Record Dates |
Last Update Posted: | May 20, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Paralysis Aphasia Supranuclear Palsy, Progressive Aphasia, Primary Progressive Pick Disease of the Brain Frontotemporal Dementia Tauopathies Neurologic Manifestations Nervous System Diseases Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Movement Disorders Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Neurodegenerative Diseases Eye Diseases Dementia Neurocognitive Disorders Mental Disorders Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |