Corticobasal Degeneration (CBD)4RTNI-2NCT02966145
4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2
An observational study of Corticobasal Degeneration (CBD) and Corticobasal Syndrome (CBS), run by University of California, San Francisco at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Corticobasal Degeneration (CBD), Corticobasal Syndrome (CBS), Cortical-basal Ganglionic Degeneration (CBGD)
- What is being tested?
- Observational Study
- How many people
- 293 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2016to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Harvard University - Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Columbia University
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of California, San Diego (UCSD)
San Diego, California, 92037
University of California, San Francisco (UCSF)
San Francisco, California, 94158
About this study
Official title: 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'.
- 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)
- Being tested
- Observational Study
- 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
- Medical subject headings
- Corticobasal Degeneration, Supranuclear Palsy, Progressive, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Observational Study | |
| o/vPSP | Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome. Receives: 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. Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tau-PET Brain Scan
Change from Baseline of Tau protein distribution in the brain.
Measured: Baseline, 1-year, and 2-years.
Amyloid-PET Brain Scan
Presence of Amyloid in the brain at Baseline.
Measured: Baseline
Brain Volume on MRI
Change from Baseline of brain tissue volume.
Measured: Baseline, 6-months, 1-year, and 2-years.
Progressive Supranuclear Palsy Rating Scale (PSPRS)
Change from Baseline of this rating scale.
Measured: Baseline, 6-months, 1-year, and 2-years.
Corticobasal Degeneration Functional Scale (CBDFS)
Change from Baseline of this rating scale.
Measured: Baseline, 6-months, 1-year, and 2-years.
Eye Movement Function
Change from Baseline of eye movement function.
Measured: Baseline, 6-months, 1-year, and 2-years.
Retinal Imaging
Change from Baseline of retinal thickness.
Measured: Baseline, 6-months, 1-year, and 2-years.
UDS Neuropsychological Testing Battery, including supplemental FTLD Module
Change fromm Baseline of cognitive function.
Measured: Baseline, 6-months, 1-year, and 2-years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJan 2016
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Corticobasal Degeneration (CBD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Adam L Boxer, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966145
- Sponsor's protocol ID
- 4RTNI-2
- Other IDs
- 2R01AG038791-06A1
- Acronym
- 4RTNI-2
- Status last verified
- Apr 2025
- First submitted
- 15 Nov 2016
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified participant data are available by request .
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.
PubMed 23359374Boxer 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.
PubMed 24873720Fagan 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.
PubMed 21555603Golbe 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.
PubMed 17405767Heuer 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.
PubMed 23986300Litvan 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.
PubMed 8710059Scherling 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.
PubMed 24242746Stamelou 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.
PubMed 20472654Steele 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.
PubMed 24963673Wagshal 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.
PubMed 24899730Scotton WJ, Shand C, Todd EG, Bocchetta M, Kobylecki C, Cash DM, VandeVrede L, Heuer HW, Quaegebeur A, Young AL, Oxtoby N, Alexander D, Rowe JB, Morris HR; PROSPECT Consortium; Boxer AL; 4RTNI Consortium; Rohrer JD, Wijeratne PA. Distinct spatiotemporal atrophy patterns in corticobasal syndrome are associated with different underlying pathologies. Brain Commun. 2025 Feb 11;7(2):fcaf066. doi: 10.1093/braincomms/fcaf066. eCollection 2025.
PubMed 40070441Wise A, Li J, Yamakawa M, Loureiro J, Peterson B, Worringer K, Sivasankaran R, Palma JA, Mitic L, Heuer HW, Lario-Lago A, Staffaroni AM, Clark A, Taylor J, Ljubenkov PA, Vandevrede L, Grinberg LT, Spina S, Seeley WW, Miller BL, Boeve BF, Dickerson BC, Grossman M, Litvan I, Pantelyat A, Tartaglia MC, Zhang Z, Wills AA, Rexach J, Rojas JC, Boxer AL; as the 4-Repeat Tauopathy Neuroimaging Initiative. CSF Proteomics in Patients With Progressive Supranuclear Palsy. Neurology. 2024 Aug 13;103(3):e209585. doi: 10.1212/WNL.0000000000209585. Epub 2024 Jul 3.
PubMed 38959435Garcia-Cordero I, Anastassiadis C, Khoja A, Morales-Rivero A, Thapa S, Vasilevskaya A, Davenport C, Sumra V, Couto B, Multani N, Taghdiri F, Anor C, Misquitta K, Vandevrede L, Heuer H, Tang-Wai D, Dickerson B, Pantelyat A, Litvan I, Boeve B, Rojas JC, Ljubenkov P, Huey E, Fox S, Kovacs GG, Boxer A, Lang A, Tartaglia MC; 4-R-Tauopathy Neuroimaging Initiative Consortium, and the Alzheimer's Disease Neuroimaging Initiative. Evaluating the Effect of Alzheimer's Disease-Related Biomarker Change in Corticobasal Syndrome and Progressive Supranuclear Palsy. Ann Neurol. 2024 Jul;96(1):99-109. doi: 10.1002/ana.26930. Epub 2024 Apr 5.
PubMed 38578117
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Four-Repeat Tauopathy Neuroimaging Initiative
- ClinicalTrials.gov ID
- NCT02966145
- Acronym / sponsor ID
- 4RTNI-2 / 4RTNI-2
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Jan 2016
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSP & CBD | – | Other: Observational StudyObservational study of participants with a diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration (also called Corticobasal Syndrome or Cortical-basal Ganglionic Degeneration). |
| o/vPSP | – | Other: Observational StudyObservational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome. |
| Normal Volunteers | – | Other: Observational StudyObservational study of participants with no known diagnosis of a neurological or neurodegenerative condition, and no known history of memory complaints. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study | Other | Normal Volunteers, PSP & CBD, o/vPSP |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 23359374Armstrong 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.
- Background: PubMed 24873720Boxer 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.
- Background: PubMed 21555603Fagan 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.
- Background: PubMed 17405767Golbe 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.
- Background: PubMed 23986300Heuer 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.
- Background: PubMed 8710059Litvan 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.
- Background: PubMed 24242746Scherling 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.
- Background: PubMed 20472654Stamelou 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.
- Background: PubMed 24963673Steele 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.
- Background: PubMed 24899730Wagshal 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.
- Background: PubMed 40070441Scotton WJ, Shand C, Todd EG, Bocchetta M, Kobylecki C, Cash DM, VandeVrede L, Heuer HW, Quaegebeur A, Young AL, Oxtoby N, Alexander D, Rowe JB, Morris HR; PROSPECT Consortium; Boxer AL; 4RTNI Consortium; Rohrer JD, Wijeratne PA. Distinct spatiotemporal atrophy patterns in corticobasal syndrome are associated with different underlying pathologies. Brain Commun. 2025 Feb 11;7(2):fcaf066. doi: 10.1093/braincomms/fcaf066. eCollection 2025.
- Results publication: PubMed 38959435Wise A, Li J, Yamakawa M, Loureiro J, Peterson B, Worringer K, Sivasankaran R, Palma JA, Mitic L, Heuer HW, Lario-Lago A, Staffaroni AM, Clark A, Taylor J, Ljubenkov PA, Vandevrede L, Grinberg LT, Spina S, Seeley WW, Miller BL, Boeve BF, Dickerson BC, Grossman M, Litvan I, Pantelyat A, Tartaglia MC, Zhang Z, Wills AA, Rexach J, Rojas JC, Boxer AL; as the 4-Repeat Tauopathy Neuroimaging Initiative. CSF Proteomics in Patients With Progressive Supranuclear Palsy. Neurology. 2024 Aug 13;103(3):e209585. doi: 10.1212/WNL.0000000000209585. Epub 2024 Jul 3.
- Individual participant dataSharing planned: Yes. Deidentified participant data are available by request .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam L Boxer, MD, PhD principal investigator
University of California, San Francisco
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corticobasal Degeneration (CBD) and Corticobasal Syndrome (CBS), run by University of California, San Francisco at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tau-PET Brain Scan (time frame: Baseline, 1-year, and 2-years.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966145, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.