Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
NCT ID: NCT04468347
Last Updated: 2020-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
89 participants
INTERVENTIONAL
2014-10-31
2018-02-28
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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Alzheimer's disease (AD)
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain
Mild cognitive impairment (MCI)
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain
Subjective memory complainers (SMC)
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain
Cognitively normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain
Interventions
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Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of electroconvulsive therapy
* MRI contraindicated
* claustrophobic or, otherwise, unable to tolerate the imaging procedure
* current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
* history of additional risk factors for Torsades de Pointes
* current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
* history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
* current drug or alcohol abuse/dependence
* history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
* females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception
60 Years
ALL
Yes
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Avid Radiopharmaceuticals, Inc.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to the Australian Imaging, Biomarker \& Lifestyle Flagship Study of Ageing (AIBL) website
Other Identifiers
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18F-AV-1451-A08
Identifier Type: -
Identifier Source: org_study_id
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