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A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

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ClinicalTrials.gov Identifier: NCT02605785
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Keith A. Josephs, Mayo Clinic

Brief Summary:
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Drug: F-18 AV 1451 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
Study Start Date : November 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Tau PET Scan, F-18 AV 1451
All subjects will received a Tau PET scan.
Drug: F-18 AV 1451
Tau PET scan
Other Name: Tau binding agent




Primary Outcome Measures :
  1. The investigators will be looking at the amount of Tau protein in the brain of patients with PSP. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Rates of change in tau-PET burden over time. [ Time Frame: baseline, 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be over 40 years of age.
  • Must have an informant or study partner that can provide independent information of functioning.
  • Must meet criteria for possible or probable Progressive Supranuclear Palsy. To fulfill criteria for possible PSP, subjects must have a gradually progressive disorder with either vertical (upward or downward) supranuclear palsy or both slowing of vertical saccades and prominent postural instability with falls in the first year of disease onset. To fulfill criteria for probable PSP, subjects must have vertical (upward or downward gaze) supranuclear palsy and prominent postural instability with falls in the first year of disease onset.
  • Must have symptoms for <4 years.
  • Must be able to ambulate independently.
  • Must have a PSP rating scale score of less than 40 and a Montreal Cognitive Assessment score of greater than 20.

Exclusion Criteria:

  • Subjects will be excluded if they meet criteria for another neurodegenerative disease (including corticobasal syndrome, frontotemporal dementia, primary progressive aphasia, Alzheimer's disease, multiple system atrophy and Parkinson's disease) or do not have the symptoms necessary to fulfill inclusion criteria for possible PSP.
  • Subjects with concurrent illnesses that could account for their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes will be excluded.
  • Women that are pregnant or post-partum and breast-feeding will be excluded.
  • Subjects will be excluded from the study if they are unable to undergo the tau-PET scan due to a prolonged QT interval on ECG, or if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome.
  • Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts), or if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy).
  • Subjects will also be excluded if they do not have an informant, or do not consent to research.

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): NCT02605785


Contacts
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Contact: Sarah M Boland, CCRP 507-284-3863 boland.sarah@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sarah M Boland, CCRP    507-284-3863    boland.sarah@mayo.edu   
Principal Investigator: Keith Josephs, MD         
Sponsors and Collaborators
Mayo Clinic

Additional Information:
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Responsible Party: Keith A. Josephs, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02605785     History of Changes
Other Study ID Numbers: 15-004618
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

Keywords provided by Keith A. Josephs, Mayo Clinic:
PSP

Additional relevant MeSH terms:
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Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms