Progressive Supranuclear Palsy4RTNINCT01804452
4 Repeat Tauopathy Neuroimaging Initiative
An observational study of Progressive Supranuclear Palsy and Corticobasal Degeneration, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate several different tests, including brain imaging, eye movement testing, body fluid samples, measurements of memory and other thinking abilities, and measures of functional independence in the hope that this information can be used to guide diagnosis and treatment of PSP and CBD… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Progressive Supranuclear Palsy, Corticobasal Degeneration
- What is being tested?
- Observational Study
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2011to 1 Mar 2016
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a diagnosis of PSP or CBD
Who may be able to join
- Clinical diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration
- Must have a reliable study partner who has frequent contact with the subject
- Willing and able to undergo testing procedures
Who cannot join
- Significant neurological disease other than PSP or CBD
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Hopkins University
Baltimore, Maryland, 21218
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Observational Longitudinal Study of Magnetic Resonance Imaging, Specimen Biomarkers, and Clinical Progression in Progressive Supranuclear Palsy and Corticobasal Degeneration
The purpose of this study is to evaluate several different tests, including brain imaging, eye movement testing, body fluid samples, measurements of memory and other thinking abilities, and measures of functional independence in the hope that this information can be used to guide diagnosis and treatment of PSP and CBD in the future. Recent advances in our understanding of the biological causes of these diseases offer hope for new treatments. As such treatments are developed, sensitive and specific biological measurements (biomarkers) will be needed to provide precise and direct measures of the state of the brain, which will improve the statistical power of clinical trials. Brain imaging with Magnetic Resonance Imaging (MRI) has previously been used to measure disease-related changes in the brain. The goal of this study is to identify the best methods of analysis (including eye movements, imaging, and behavioral measures) for tracking PSP and CBD over time. In addition, certain biomarkers in the blood and cerebrospinal fluid might also be useful for following these diseases over time. This study will examine the value of blood and CSF biomarkers relative to brain imaging and functional measures.
- Being tested
- Observational Study
- Keywords
- Progressive Supranuclear Palsy, Corticobasal Degeneration, Biomarker, Neuroimaging, MRI, Tau, Oculomotor
- Medical subject headings
- Supranuclear Palsy, Progressive, Corticobasal Degeneration, 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 |
|---|---|---|
| Subjects with a diagnosis of PSP or CBD | Not described Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive Supranuclear Palsy Rating Scale
Change from baseline
Measured: Baseline, 6 months and 1 year
Secondary outcomes (2)
Eye movement function
Change from baseline
Measured: Baseline, 6 months and 1 year
Brain volume on MRI
Change from baseline.
Measured: Baseline, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study start10 Jan 2011
- Primary completion28 Feb 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Progressive Supranuclear PalsyStudies 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
- 110 participants (estimated)
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 Boxer, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804452
- Sponsor's protocol ID
- 4RTNI
- Other IDs
- R01AG031278
- Acronym
- 4RTNI
- Status last verified
- May 2025
- First submitted
- 18 Jan 2013
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SE, Rabinovici GD, Mayo MC, Wilson SM, Seeley WW, DeArmond SJ, Huang EJ, Trojanowski JQ, Growdon ME, Jang JY, Sidhu M, See TM, Karydas AM, Gorno-Tempini ML, Boxer AL, Weiner MW, Geschwind MD, Rankin KP, Miller BL. Clinicopathological correlations in corticobasal degeneration. Ann Neurol. 2011 Aug;70(2):327-40. doi: 10.1002/ana.22424.
PubMed 21823158Coppola G, Chinnathambi S, Lee JJ, Dombroski BA, Baker MC, Soto-Ortolaza AI, Lee SE, Klein E, Huang AY, Sears R, Lane JR, Karydas AM, Kenet RO, Biernat J, Wang LS, Cotman CW, Decarli CS, Levey AI, Ringman JM, Mendez MF, Chui HC, Le Ber I, Brice A, Lupton MK, Preza E, Lovestone S, Powell J, Graff-Radford N, Petersen RC, Boeve BF, Lippa CF, Bigio EH, Mackenzie I, Finger E, Kertesz A, Caselli RJ, Gearing M, Juncos JL, Ghetti B, Spina S, Bordelon YM, Tourtellotte WW, Frosch MP, Vonsattel JP, Zarow C, Beach TG, Albin RL, Lieberman AP, Lee VM, Trojanowski JQ, Van Deerlin VM, Bird TD, Galasko DR, Masliah E, White CL, Troncoso JC, Hannequin D, Boxer AL, Geschwind MD, Kumar S, Mandelkow EM, Wszolek ZK, Uitti RJ, Dickson DW, Haines JL, Mayeux R, Pericak-Vance MA, Farrer LA; Alzheimer's Disease Genetics Consortium; Ross OA, Rademakers R, Schellenberg GD, Miller BL, Mandelkow E, Geschwind DH. Evidence for a role of the rare p.A152T variant in MAPT in increasing the risk for FTD-spectrum and Alzheimer's diseases. Hum Mol Genet. 2012 Aug 1;21(15):3500-12. doi: 10.1093/hmg/dds161. Epub 2012 May 3.
PubMed 22556362Garbutt S, Matlin A, Hellmuth J, Schenk AK, Johnson JK, Rosen H, Dean D, Kramer J, Neuhaus J, Miller BL, Lisberger SG, Boxer AL. Oculomotor function in frontotemporal lobar degeneration, related disorders and Alzheimer's disease. Brain. 2008 May;131(Pt 5):1268-81. doi: 10.1093/brain/awn047. Epub 2008 Mar 24.
PubMed 18362099Boxer AL, Geschwind MD, Belfor N, Gorno-Tempini ML, Schauer GF, Miller BL, Weiner MW, Rosen HJ. Patterns of brain atrophy that differentiate corticobasal degeneration syndrome from progressive supranuclear palsy. Arch Neurol. 2006 Jan;63(1):81-6. doi: 10.1001/archneur.63.1.81.
PubMed 16401739Belfor N, Amici S, Boxer AL, Kramer JH, Gorno-Tempini ML, Rosen HJ, Miller BL. Clinical and neuropsychological features of corticobasal degeneration. Mech Ageing Dev. 2006 Feb;127(2):203-7. doi: 10.1016/j.mad.2005.09.013. Epub 2005 Nov 28.
PubMed 16310834
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Longitudinal Study of Magnetic Resonance Imaging, Specimen Biomarkers, and Clinical Progression in Progressive Supranuclear Palsy and Corticobasal Degeneration
- ClinicalTrials.gov ID
- NCT01804452
- Acronym / sponsor ID
- 4RTNI / 4RTNI
- Keywords
- Progressive Supranuclear Palsy, Corticobasal Degeneration, Biomarker, Neuroimaging, MRI, Tau, Oculomotor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 10 Jan 2011 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 5 Mar 2013 (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 purpose of this study is to evaluate several different tests, including brain imaging, eye movement testing, body fluid samples, measurements of memory and other thinking abilities, and measures of functional independence in the hope that this information can be used to guide diagnosis and treatment of PSP and CBD in the future. Recent advances in our understanding of the biological causes of these diseases offer hope for new treatments. As such treatments are developed, sensitive and specific biological measurements (biomarkers) will be needed to provide precise and direct measures of the state of the brain, which will improve the statistical power of clinical trials. Brain imaging with Magnetic Resonance Imaging (MRI) has previously been used to measure disease-related changes in the brain. The goal of this study is to identify the best methods of analysis (including eye movements, imaging, and behavioral measures) for tracking PSP and CBD over time. In addition, certain biomarkers in the blood and cerebrospinal fluid might also be useful for following these diseases over time. This study will examine the value of blood and CSF biomarkers relative to brain imaging and functional measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with a diagnosis of PSP or CBD | – | Other: Observational Study |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a diagnosis of PSP or CBD
Key inclusion criteria (3 listed)
- Clinical diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration
- Must have a reliable study partner who has frequent contact with the subject
- Willing and able to undergo testing procedures
Key exclusion criteria (2 listed)
- Significant neurological disease other than PSP or CBD
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
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 | Subjects with a diagnosis of PSP or CBD |
Primary outcome
Progressive Supranuclear Palsy Rating Scale
Time frame: Baseline, 6 months and 1 year
Change from baseline
2 secondary outcomes
Eye movement function
Time frame: Baseline, 6 months and 1 year
Brain volume on MRI
Time frame: Baseline, 6 months and 1 year
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 8 May 2025.
- Background: PubMed 21823158Lee SE, Rabinovici GD, Mayo MC, Wilson SM, Seeley WW, DeArmond SJ, Huang EJ, Trojanowski JQ, Growdon ME, Jang JY, Sidhu M, See TM, Karydas AM, Gorno-Tempini ML, Boxer AL, Weiner MW, Geschwind MD, Rankin KP, Miller BL. Clinicopathological correlations in corticobasal degeneration. Ann Neurol. 2011 Aug;70(2):327-40. doi: 10.1002/ana.22424.
- Background: PubMed 22556362Coppola G, Chinnathambi S, Lee JJ, Dombroski BA, Baker MC, Soto-Ortolaza AI, Lee SE, Klein E, Huang AY, Sears R, Lane JR, Karydas AM, Kenet RO, Biernat J, Wang LS, Cotman CW, Decarli CS, Levey AI, Ringman JM, Mendez MF, Chui HC, Le Ber I, Brice A, Lupton MK, Preza E, Lovestone S, Powell J, Graff-Radford N, Petersen RC, Boeve BF, Lippa CF, Bigio EH, Mackenzie I, Finger E, Kertesz A, Caselli RJ, Gearing M, Juncos JL, Ghetti B, Spina S, Bordelon YM, Tourtellotte WW, Frosch MP, Vonsattel JP, Zarow C, Beach TG, Albin RL, Lieberman AP, Lee VM, Trojanowski JQ, Van Deerlin VM, Bird TD, Galasko DR, Masliah E, White CL, Troncoso JC, Hannequin D, Boxer AL, Geschwind MD, Kumar S, Mandelkow EM, Wszolek ZK, Uitti RJ, Dickson DW, Haines JL, Mayeux R, Pericak-Vance MA, Farrer LA; Alzheimer's Disease Genetics Consortium; Ross OA, Rademakers R, Schellenberg GD, Miller BL, Mandelkow E, Geschwind DH. Evidence for a role of the rare p.A152T variant in MAPT in increasing the risk for FTD-spectrum and Alzheimer's diseases. Hum Mol Genet. 2012 Aug 1;21(15):3500-12. doi: 10.1093/hmg/dds161. Epub 2012 May 3.
- Background: PubMed 18362099Garbutt S, Matlin A, Hellmuth J, Schenk AK, Johnson JK, Rosen H, Dean D, Kramer J, Neuhaus J, Miller BL, Lisberger SG, Boxer AL. Oculomotor function in frontotemporal lobar degeneration, related disorders and Alzheimer's disease. Brain. 2008 May;131(Pt 5):1268-81. doi: 10.1093/brain/awn047. Epub 2008 Mar 24.
- Background: PubMed 16401739Boxer AL, Geschwind MD, Belfor N, Gorno-Tempini ML, Schauer GF, Miller BL, Weiner MW, Rosen HJ. Patterns of brain atrophy that differentiate corticobasal degeneration syndrome from progressive supranuclear palsy. Arch Neurol. 2006 Jan;63(1):81-6. doi: 10.1001/archneur.63.1.81.
- Background: PubMed 16310834Belfor N, Amici S, Boxer AL, Kramer JH, Gorno-Tempini ML, Rosen HJ, Miller BL. Clinical and neuropsychological features of corticobasal degeneration. Mech Ageing Dev. 2006 Feb;127(2):203-7. doi: 10.1016/j.mad.2005.09.013. Epub 2005 Nov 28.
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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 Boxer, MD, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Supranuclear Palsy and Corticobasal Degeneration, run by University of California, San Francisco at 2 sites in United States.
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 3 inclusion and 2 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 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Progressive Supranuclear Palsy Rating Scale (time frame: Baseline, 6 months and 1 year). 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 NCT01804452, which also lists 5 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 8 May 2025.