Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
NCT ID: NCT03901105
Last Updated: 2020-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
205 participants
INTERVENTIONAL
2019-03-28
2019-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Flortaucipir PET Scan
No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) will be read by independent, blinded readers.
flortaucipir F18
No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES
Brain PET Scan
positron emission tomography (PET) scan of the brain
Interventions
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flortaucipir F18
No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES
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
* Board-certified in radiology or nuclear medicine
* Professional experience interpreting PET scans
Scan Criteria (205 total scans):
* Former enrollment in AZES Study
* Flortaucipir scan at baseline
* clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months
Scan Study Population (AZES Study):
* 55 to 85 years
* MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association criteria (Albert 2011
* mini-mental status exam (MMSE) of 20 to 30 inclusive
* CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score ≥ 0.5, and a score of ≤85 on the Delayed Memory Index of the Repeatable Battery for the Assessment of Neuropsychological Status.
* Amyloid positive status confirmed by florbetapir PET or lumbar puncture
55 Years
85 Years
ALL
No
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Avid Radiopharmaceuticals
Locations
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American College of Radiology
Philadelphia, Pennsylvania, United States
Countries
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References
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Lu M, Pontecorvo MJ, Devous MD Sr, Arora AK, Galante N, McGeehan A, Devadanam C, Salloway SP, Doraiswamy PM, Curtis C, Truocchio SP, Flitter M, Locascio T, Devine M, Zimmer JA, Fleisher AS, Mintun MA; AVID Collaborators. Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. JAMA Neurol. 2021 Apr 1;78(4):445-453. doi: 10.1001/jamaneurol.2020.5505.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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18F-AV-1451-PX01
Identifier Type: -
Identifier Source: org_study_id
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