- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02167594
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
August 21, 2020 updated by: Avid Radiopharmaceuticals
18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy Volunteers
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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California
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La Jolla, California, United States, 92037
- UCSD Movement Disorder Clinic
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San Francisco, California, United States, 94158
- UCSF Neurosciences Clinical Research Unit
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Connecticut
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New Haven, Connecticut, United States, 06510
- Molecular NeuroImaging
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Perelman School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PSP Subjects
Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
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IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
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Experimental: CBD subjects
Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.
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IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
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Experimental: Healthy volunteers
Healthy volunteers receiving a flortaucipir PET scan at baseline.
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IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
Time Frame: baseline and 9 month scans
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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.
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baseline and 9 month scans
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Avid Radiopharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2014
Primary Completion (Actual)
July 11, 2016
Study Completion (Actual)
July 11, 2016
Study Registration Dates
First Submitted
June 17, 2014
First Submitted That Met QC Criteria
June 18, 2014
First Posted (Estimate)
June 19, 2014
Study Record Updates
Last Update Posted (Actual)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 21, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18F-AV-1451-A09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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