stop_circleTerminated/Withdrawn
Alzheimer Disease
Bayer Identifier:
14595
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
STUDY SPONSORSHIP TRANSFERRED - Phase III study of Florbetaben (BAY94-9172) PET imaging for detection/exclusion of cerebral β-amyloid compared to histopathology
Trial purpose
DISCLAIMER: This study was originally conducted and disclosed under Bayer sponsorship; sponsorship was however transferred to a new sponsor while the study was still ongoing. Therefore, this disclosure overview only reflects the study status at the last time that Bayer was responsible for the study – for the latest correct status and details of the study, please refer to the disclosure by the new sponsor under the study’s NCT number on www.ClinicalTrials.gov.
To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
Key Participants Requirements
Sex
BothAge
21 YearsTrial summary
Enrollment Goal
216Trial Dates
November 2009 - December 2012Phase
Phase 3Could I Receive a placebo
NoProducts
NEURACEQ (Florbetaben F-18, BAY94-9172)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Leipzig, 04103, Germany | |
Completed | Sun City, 85351, United States | |
Completed | Teaneck, 07666, United States | |
Completed | Stanford, 94305, United States | |
Completed | Tampa, 33616, United States | |
Completed | LILLE, 59037, France | |
Withdrawn | Itabashi-ku, 173-0015, Japan | |
Terminated | Toyohashi, 441-8124, Japan | |
Withdrawn | Toyohashi, 441-8029, Japan | |
Completed | Heidelberg, 3084, Australia | |
Completed | Jülich, 52425, Germany | |
Completed | San Antonio, 78229, United States | |
Terminated | Itabashi-ku, 173-0015, Japan | |
Terminated | Isezaki, 372-0006, Japan | |
Withdrawn | Hamamatsu, 432-8580, Japan | |
Completed | Dallas, 75390, United States | |
Completed | Philadelphia, 19104, United States | |
Withdrawn | Toyohashi, 440-0045, Japan | |
Withdrawn | Houston, 77030, United States | |
Completed | STRASBOURG, 67091, France |
Primary Outcome
- Sensitivity and specificity of the visual assessment of tracer uptake compared to histological verification of the presence or absence of cerebral beta-amyloid in postmortem specimensdate_rangeTime Frame:On day 1 - one scanning period after injectionenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Sensitivity and specificity of the composite “whole brain” regional visual assessment in detecting/excluding cerebral β-amyloid plaques based on the "whole brain" histopathological verification of the presence/absence of ß-amyloid depositiondate_rangeTime Frame:On day 1 - one scanning period after injectionenhanced_encryptionnoSafety Issue:
- Sensitivity and specificity of the quantitative assessment of regional tracer uptake in BAY94-9172 PET images compared to histological verification of presence/absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truthdate_rangeTime Frame:On day 1 - one scanning period after injectionenhanced_encryptionnoSafety Issue:
- Sensitivity and specificity of the visual assessment of BAY 94-9172 PET images on the subject level (according to the RCTU and BAPL rating scale) in detecting/excluding cerebral β-amyloid compared to the onsite neuropathological diagnosisdate_rangeTime Frame:On day 1 - one scanning period after injectionenhanced_encryptionnoSafety Issue:
- To evaluate the safety and tolerability of a single dose of BAY94-9172date_rangeTime Frame:8 daysenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1