NCT01804452

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

5.1 years

First QC Date

January 18, 2013

Last Update Submit

May 5, 2025

Conditions

Progressive Supranuclear PalsyCorticobasal Degeneration

Keywords

Progressive Supranuclear PalsyCorticobasal DegenerationBiomarkerNeuroimagingMRITauOculomotor

Outcome Measures

Primary Outcomes (1)

  • Progressive Supranuclear Palsy Rating Scale

    Change from baseline

    Baseline, 6 months and 1 year

Secondary Outcomes (2)

  • Eye movement function

    Baseline, 6 months and 1 year

  • Brain volume on MRI

    Baseline, 6 months and 1 year

Study Arms (1)

Subjects with a diagnosis of PSP or CBD

Other: Observational Study

Interventions

Observational StudyOTHER
Subjects with a diagnosis of PSP or CBD

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with a diagnosis of PSP or CBD

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

John Hopkins University

Baltimore, Maryland, 21218, United States

Location

Related Publications (5)

  • 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.

    PMID: 21823158BACKGROUND

  • Coppola 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.

    PMID: 22556362BACKGROUND

  • Garbutt 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.

    PMID: 18362099BACKGROUND

  • Boxer 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.

    PMID: 16401739BACKGROUND

  • Belfor 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.

    PMID: 16310834BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, urine, cell lines and cerebrospinal fluid will be retained by study investigators.

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveCorticobasal DegenerationPick Disease of the Brain

Interventions

Observation

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFrontotemporal DementiaFrontotemporal Lobar DegenerationDementiaNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Adam Boxer, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2013

First Posted

March 5, 2013

Study Start

January 10, 2011

Primary Completion

February 28, 2016

Study Completion

March 1, 2016

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations

US(2)