Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects
NCT ID: NCT04474405
Last Updated: 2020-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
36 participants
INTERVENTIONAL
2013-08-16
2013-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Brain flortaucipir PET scan
Subjects receiving a brain PET scan after flortaucipir administration
Flortaucipir F18
IV injection, 370 MBq (10 mCi), single dose
Brain PET Scan
positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).
Florbetapir F 18
IV injection, 370 MBq (10 mCi), single dose
Brain MRI
Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain
Whole body flortaucipir PET scan
Subjects receiving a whole body PET scan after flortaucipir administration
Flortaucipir F18
IV injection, 370 MBq (10 mCi), single dose
Whole body PET scan
positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours
MRI and Amyloid Extension Cohort
Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355)
Brain PET Scan
positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).
Florbetapir F 18
IV injection, 370 MBq (10 mCi), single dose
Brain MRI
Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain
Interventions
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Flortaucipir F18
IV injection, 370 MBq (10 mCi), single dose
Brain PET Scan
positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).
Whole body PET scan
positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours
Florbetapir F 18
IV injection, 370 MBq (10 mCi), single dose
Brain MRI
Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
* Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)
Exclusion Criteria
* Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
* Claustrophobic or otherwise unable to tolerate the imaging procedure.
* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval \>450 msec).
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol abuse or substance abuse or dependence
* Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
* Required medications with a narrow therapeutic window
* Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session
* Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days
20 Years
ALL
Yes
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Avid Radiopharmaceuticals, Inc.
Locations
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WCCT Global, LLC
Cypress, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Countries
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Other Identifiers
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18F-AV-1451-A01
Identifier Type: -
Identifier Source: org_study_id
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