- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02966145
4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2 (4RTNI-2)
January 22, 2024 updated by: University of California, San Francisco
The Four-Repeat Tauopathy Neuroimaging Initiative
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'.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
232
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adam Boxer, MD, Phd
- Phone Number: (415) 476-0668
- Email: adam.boxer@ucsf.edu
Study Contact Backup
- Name: Hilary Heuer, PhD
- Phone Number: (415) 476-6743
- Email: Hilary.Heuer@ucsf.edu
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- University of Toronto
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California
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San Diego, California, United States, 92037
- University of California, San Diego (UCSD)
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San Francisco, California, United States, 94158
- University of California, San Francisco (UCSF)
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Massachusetts
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Charlestown, Massachusetts, United States, 02129
- Harvard University - Massachusetts General Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic - Rochester
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New York
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New York, New York, United States, 10032
- Columbia University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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).
|
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o/vPSP
Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tau-PET Brain Scan
Time Frame: Baseline, 1-year, and 2-years.
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Change from Baseline of Tau protein distribution in the brain.
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Baseline, 1-year, and 2-years.
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Amyloid-PET Brain Scan
Time Frame: Baseline
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Presence of Amyloid in the brain at Baseline.
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Baseline
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Brain Volume on MRI
Time Frame: Baseline, 6-months, 1-year, and 2-years.
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Change from Baseline of brain tissue volume.
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Baseline, 6-months, 1-year, and 2-years.
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Progressive Supranuclear Palsy Rating Scale (PSPRS)
Time Frame: Baseline, 6-months, 1-year, and 2-years.
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Change from Baseline of this rating scale.
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Baseline, 6-months, 1-year, and 2-years.
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Corticobasal Degeneration Functional Scale (CBDFS)
Time Frame: Baseline, 6-months, 1-year, and 2-years.
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Change from Baseline of this rating scale.
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Baseline, 6-months, 1-year, and 2-years.
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Eye Movement Function
Time Frame: Baseline, 6-months, 1-year, and 2-years.
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Change from Baseline of eye movement function.
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Baseline, 6-months, 1-year, and 2-years.
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Retinal Imaging
Time Frame: Baseline, 6-months, 1-year, and 2-years.
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Change from Baseline of retinal thickness.
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Baseline, 6-months, 1-year, and 2-years.
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UDS Neuropsychological Testing Battery, including supplemental FTLD Module
Time Frame: Baseline, 6-months, 1-year, and 2-years.
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Change fromm Baseline of cognitive function.
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Baseline, 6-months, 1-year, and 2-years.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adam L Boxer, MD, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Armstrong MJ, Litvan I, Lang AE, Bak TH, Bhatia KP, Borroni B, Boxer AL, Dickson DW, Grossman M, Hallett M, Josephs KA, Kertesz A, Lee SE, Miller BL, Reich SG, Riley DE, Tolosa E, Troster AI, Vidailhet M, Weiner WJ. Criteria for the diagnosis of corticobasal degeneration. Neurology. 2013 Jan 29;80(5):496-503. doi: 10.1212/WNL.0b013e31827f0fd1.
- Boxer AL, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Golbe LI, Williams DR, Corvol JC, Ludolph A, Burn D, Lorenzl S, Litvan I, Roberson ED, Hoglinger GU, Koestler M, Jack CR Jr, Van Deerlin V, Randolph C, Lobach IV, Heuer HW, Gozes I, Parker L, Whitaker S, Hirman J, Stewart AJ, Gold M, Morimoto BH; AL-108-231 Investigators. Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial. Lancet Neurol. 2014 Jul;13(7):676-85. doi: 10.1016/S1474-4422(14)70088-2. Epub 2014 May 27.
- Litvan I, Agid Y, Calne D, Campbell G, Dubois B, Duvoisin RC, Goetz CG, Golbe LI, Grafman J, Growdon JH, Hallett M, Jankovic J, Quinn NP, Tolosa E, Zee DS. Clinical research criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome): report of the NINDS-SPSP international workshop. Neurology. 1996 Jul;47(1):1-9. doi: 10.1212/wnl.47.1.1.
- Golbe LI, Ohman-Strickland PA. A clinical rating scale for progressive supranuclear palsy. Brain. 2007 Jun;130(Pt 6):1552-65. doi: 10.1093/brain/awm032. Epub 2007 Apr 2.
- Fagan AM, Shaw LM, Xiong C, Vanderstichele H, Mintun MA, Trojanowski JQ, Coart E, Morris JC, Holtzman DM. Comparison of analytical platforms for cerebrospinal fluid measures of beta-amyloid 1-42, total tau, and p-tau181 for identifying Alzheimer disease amyloid plaque pathology. Arch Neurol. 2011 Sep;68(9):1137-44. doi: 10.1001/archneurol.2011.105. Epub 2011 May 9.
- Heuer HW, Mirsky JB, Kong EL, Dickerson BC, Miller BL, Kramer JH, Boxer AL. Antisaccade task reflects cortical involvement in mild cognitive impairment. Neurology. 2013 Oct 1;81(14):1235-43. doi: 10.1212/WNL.0b013e3182a6cbfe. Epub 2013 Aug 28.
- Scherling CS, Hall T, Berisha F, Klepac K, Karydas A, Coppola G, Kramer JH, Rabinovici G, Ahlijanian M, Miller BL, Seeley W, Grinberg LT, Rosen H, Meredith J Jr, Boxer AL. Cerebrospinal fluid neurofilament concentration reflects disease severity in frontotemporal degeneration. Ann Neurol. 2014 Jan;75(1):116-26. doi: 10.1002/ana.24052. Epub 2014 Jan 2.
- Stamelou M, de Silva R, Arias-Carrion O, Boura E, Hollerhage M, Oertel WH, Muller U, Hoglinger GU. Rational therapeutic approaches to progressive supranuclear palsy. Brain. 2010 Jun;133(Pt 6):1578-90. doi: 10.1093/brain/awq115. Epub 2010 May 14.
- Steele JC, Richardson JC, Olszewski J. Progressive supranuclear palsy: a heterogeneous degeneration involving the brain stem, Basal Ganglia and cerebellum with vertical gaze and pseudobulbar palsy, nuchal dystonia and dementia. Semin Neurol. 2014 Apr;34(2):129-50. doi: 10.1055/s-0034-1377058. Epub 2014 Jun 25. No abstract available.
- Wagshal D, Sankaranarayanan S, Guss V, Hall T, Berisha F, Lobach I, Karydas A, Voltarelli L, Scherling C, Heuer H, Tartaglia MC, Miller Z, Coppola G, Ahlijanian M, Soares H, Kramer JH, Rabinovici GD, Rosen HJ, Miller BL, Meredith J, Boxer AL. Divergent CSF tau alterations in two common tauopathies: Alzheimer's disease and progressive supranuclear palsy. J Neurol Neurosurg Psychiatry. 2015 Mar;86(3):244-50. doi: 10.1136/jnnp-2014-308004. Epub 2014 Jun 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 15, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimated)
November 17, 2016
Study Record Updates
Last Update Posted (Estimated)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
- MRI
- Biomarker
- PET
- Progressive Supranuclear Palsy
- Corticobasal Degeneration
- PSP
- CBD
- CBGD
- Neuroimaging
- Tau
- Retinal Imaging
- Corticobasal Syndrome
- Oculomotor
- CBS
- nfvPPA
- oPSP
- vPSP
- o/vPSP
- Cortocal-basal Ganglionic Degeneration
- Nonfluent Variant Primary Progressive Aphasia
- Oligosymptomatic Progressive Supranuclear Palsy
- Variant Progressive Supranuclear Palsy
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Ophthalmoplegia
- Paralysis
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Supranuclear Palsy, Progressive
- Tauopathies
- Corticobasal Degeneration
Other Study ID Numbers
- 4RTNI-2
- 2R01AG038791-06A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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