Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology
NCT ID: NCT01020838
Last Updated: 2016-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2009-11-30
2013-12-31
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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Florbetaben (BAY94-9172)
Florbetaben (BAY94-9172)
Single intravenous injection 1-5ml, 300 MBq (+/- 20%)
Interventions
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Florbetaben (BAY94-9172)
Single intravenous injection 1-5ml, 300 MBq (+/- 20%)
Eligibility Criteria
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Inclusion Criteria
* Exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures
* Is willing and able to lie down in magnetic resonance imaging (MRI) and positron emission tomography (PET) scanners
* Is willing to donate their brain for postmortem examination in case of death
* The subject, or the subject and/or legally acceptable representative will be compliant and have a high probability of completing the study in the opinion of the investigator
* Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative
* The subjects who have participated in a previous florbetaben study e.g. study 311741 may be included in the present study. The MRI- and florbetaben PET scan do not need to be repeated if both scans were performed within twelve months prior to inclusion.
Exclusion Criteria
* Has any contraindication to magnetic resonance imaging (MRI) examination, eg, metal implants or phobia as determined by the onsite radiologist performing the scan
* Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
* Has severe cardio-vascular instability requiring intensive care surveillance and/or therapeutic intervention (i.e. catecholamine infusion)
21 Years
ALL
No
Sponsors
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Life Molecular Imaging SA
INDUSTRY
Responsible Party
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Principal Investigators
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Piramal Imaging SA Study Director
Role: STUDY_DIRECTOR
Life Molecular Imaging SA
Locations
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Sun City, Arizona, United States
Stanford, California, United States
Tampa, Florida, United States
Teaneck, New Jersey, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Heidelberg, Victoria, Australia
Lille, , France
Strasbourg, , France
Jülich, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Toyohashi, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Isesaki, Gunma, Japan
Hamamatsu, Shizuoka, Japan
Itabashi-ku, Tokyo, Japan
Countries
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References
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Seibyl J, Catafau AM, Barthel H, Ishii K, Rowe CC, Leverenz JB, Ghetti B, Ironside JW, Takao M, Akatsu H, Murayama S, Bullich S, Mueller A, Koglin N, Schulz-Schaeffer WJ, Hoffmann A, Sabbagh MN, Stephens AW, Sabri O. Impact of Training Method on the Robustness of the Visual Assessment of 18F-Florbetaben PET Scans: Results from a Phase-3 Study. J Nucl Med. 2016 Jun;57(6):900-6. doi: 10.2967/jnumed.115.161927. Epub 2016 Jan 28.
Sabri O, Sabbagh MN, Seibyl J, Barthel H, Akatsu H, Ouchi Y, Senda K, Murayama S, Ishii K, Takao M, Beach TG, Rowe CC, Leverenz JB, Ghetti B, Ironside JW, Catafau AM, Stephens AW, Mueller A, Koglin N, Hoffmann A, Roth K, Reininger C, Schulz-Schaeffer WJ; Florbetaben Phase 3 Study Group. Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: phase 3 study. Alzheimers Dement. 2015 Aug;11(8):964-74. doi: 10.1016/j.jalz.2015.02.004. Epub 2015 Mar 28.
Other Identifiers
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2009-012569-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14595
Identifier Type: -
Identifier Source: org_study_id
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