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Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167594
Recruitment Status : Completed
First Posted : June 19, 2014
Results First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Brief Summary:
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Corticobasal Degeneration Drug: Flortaucipir F18 Procedure: Brain PET scan Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy Volunteers
Actual Study Start Date : August 12, 2014
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : July 11, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PSP Subjects
Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
 Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
  • [F18]T807
  • 18F-AV-1451
  • LY3191748
  • Tauvid

Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
Experimental: CBD subjects
Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.
 Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
  • [F18]T807
  • 18F-AV-1451
  • LY3191748
  • Tauvid

Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
Experimental: Healthy volunteers
Healthy volunteers receiving a flortaucipir PET scan at baseline.
 Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
  • [F18]T807
  • 18F-AV-1451
  • LY3191748
  • Tauvid

Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection


Outcome Measures
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Primary Outcome Measures :
  1. Flortaucipir Imaging in PSP, CBD and Healthy Volunteers [ Time Frame: baseline and 9 month scans ]
    A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Cognitively Healthy Volunteers

  • Mini-mental state examination (MMSE) ≥ 28
  • No history of cognitive decline or parkinsonian motor disorder

CBD and PSP subjects

  • Able to walk 10 steps with minimal assistance
  • MMSE ≥ 14 and ≤ 30
  • Subject has a reliable study partner who agrees to accompany subject to visits and spends at least 5 hours per week with the subject

PSP subjects only

  • Meet National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial

CBD subjects only

  • Meets 2013 consensus criteria for possible or probable corticobasal degeneration, corticobasal syndrome (CBS) subtype

Exclusion Criteria:

All subjects

  • Have evidence of structural abnormalities such as vascular disease, large strokes or severe white matter disease or other mass lesion on screening MRI
  • Claustrophobia
  • Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (e.g. corrected QT interval >450 msec)
  • Have a history of risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
  • Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
  • Have a history of neuroleptic use for a prolonged period of time or within the past 6 months

PSP and CBD subjects

  • Have evidence of amyloid deposition
  • Meet National Institute on Aging-Alzheimer's Association criteria for probable Alzheimer's Disease
  • Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits
  • Serum or plasma progranulin level less than one standard deviation below the normal subject mean for the laboratory performing the assay
  • Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43 pathology or known mutations
Contacts and Locations
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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): NCT02167594


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCSD Movement Disorder Clinic
La Jolla, California, United States, 92037
UCSF Neurosciences Clinical Research Unit
San Francisco, California, United States, 94158
United States, Connecticut
Molecular Neuroimaging
New Haven, Connecticut, United States, 06510
United States, Pennsylvania
Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Medical Director Avid Radiopharmaceuticals, Inc.
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02167594    
Other Study ID Numbers: 18F-AV-1451-A09
First Posted: June 19, 2014    Key Record Dates
Results First Posted: August 28, 2020
Last Update Posted: August 28, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Supranuclear Palsy, Progressive
Paralysis
Neurologic Manifestations
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases