Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2 (4RTNI-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02966145
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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'.

Condition or disease Intervention/treatment
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

Layout table for study information
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
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).
Other: Observational Study
o/vPSP
Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome.
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.
Other: Observational Study



Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Plasma, serum, cell lines and cerebrospinal fluid (CSF) will be retained by study investigators and stored at NIH-funded repositories.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
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.
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Eliya Ben-Asher, BS (415) 476-2941 Eliya.Ben-Asher@ucsf.edu
Contact: Hilary Heuer, PhD (415) 476-6743 Hilary.Heuer@ucsf.edu

Locations
Layout table for location information
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: Eliya Ben-Asher, BS    415-476-2941    Eliya.Ben-Asher@ucsf.edu   
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, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Courtney Igne    215-662-3596    cigne@mail.med.upenn.edu   
Principal Investigator: Murray Grossman, 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         
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Adam L Boxer, MD, PhD University of California, San Francisco

Publications:

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02966145     History of Changes
Other Study ID Numbers: 4RTNI-2
2R01AG038791-06A1 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, San Francisco:
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Paralysis
Aphasia
Supranuclear Palsy, Progressive
Tauopathies
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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