check_circleStudy Completed
Alzheimer Disease, Amyloid beta-Protein
Bayer Identifier:
91708
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase II study of Florbetaben (BAY 94-9172) PET imaging for detection/exclusion of cerebral β-amyloid in patients with probable Alzheimer’s disease compared to healthy volunteers
Trial purpose
The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for visually assessing and diagnosing Alzheimer's disease.For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day.The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers.The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations
Key Participants Requirements
Sex
BothAge
55 YearsTrial summary
Enrollment Goal
422Trial Dates
August 2008 - November 2010Phase
Phase 2Could I Receive a placebo
NoProducts
NEURACEQ (Florbetaben F-18, BAY94-9172)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | Universität Erlangen-Nürnberg | Erlangen, 91054, Germany |
Completed | Universitätsklinikum Essen | Essen, 45122, Germany |
Completed | Universitätsklinikum Münster | Münster, 48149, Germany |
Completed | Forschungszentrum Jülich GmbH | Jülich, 52425, Germany |
Completed | Columbia University | New York, 10032, United States |
Completed | Institute for Neurodegenerative Disorders | New Haven, 06510, United States |
Completed | New York University School of Medicine | New York, 10016, United States |
Completed | Montefiore Medical Center | Bronx, 10461, United States |
Completed | Butler Hospital | Providence, 02906, United States |
Completed | Nippon Medical School Hospital | Bunkyo-ku, 113-8603, Japan |
Completed | Austin and Repatriation Centre | Heidelberg, 3084, Australia |
Completed | Westmead Hospital | Westmead, 2145, Australia |
Completed | Universitätsspital Zürich | Zürich, 8091, Switzerland |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, 04103, Germany |
Completed | Klinikum rechts der Isar | München, 81675, Germany |
Completed | Klinikum Innenstadt der Ludwigs-Maximilians-Universität | München, 81377, Germany |
Completed | HELIOS Klinikum Berlin - Buch | Berlin, 13125, Germany |
Completed | Yale University School of Medicine | New Haven, 06510, United States |
Completed | Banner Sun Health Research Institute | Sun City, 85351, United States |
Completed | Stanford Hospital & Clinics | Stanford, 94305, United States |
Completed | Kobe University Hospital | Kobe, 650-0017, Japan |
Completed | Institute of Biomedical Research and Innovation | Kobe, 650-0047, Japan |
Completed | Royal Adelaide Hospital | Adelaide, 5000, Australia |
Primary Outcome
- To determine the sensitivity and specificity of the independent visual assessment of detecting/excluding cerebral amyloid betadate_rangeTime Frame:Two separate scanning periods will be performed after IMP injectionenhanced_encryptionnoSafety Issue:
- To determine the sensitivity and specificity of the independent visual assessment of detecting/excluding cerebral amyloid beta. The clinical diagnosis in Part B will be established by an independent consensus panel (CP)of experts in dementiadate_rangeTime Frame:Two separate scanning periods will be performed after IMP injectionenhanced_encryptionnoSafety Issue:
Secondary Outcome
- To determine the usefulness of two additional imaging windows for the visual assessmentdate_rangeTime Frame:Two separate scanning periods will be performed after IMP injectionenhanced_encryptionnoSafety Issue:
- To evaluate the proposed visual assessment procedure and subsequent classificationdate_rangeTime Frame:Two separate scanning periods will be performed after study product injectionenhanced_encryptionnoSafety Issue:
- To assess various quantitative PET image analysis methodsdate_rangeTime Frame:Two separate scanning periods will be performed after study product injection 7 daysenhanced_encryptionnoSafety Issue:
- To evaluate the safety and tolerabilitydate_rangeTime Frame:Two seperate scanning periods will be performed after IMP injectionenhanced_encryptionyesSafety Issue:
- To determine the sensitivity specificity of both, volume of interest (VOI) and voxol based quantitative image analysis in detecting/excluding cerebral beta-amyloid when compared to the independent CP diagnosis as the standard of truthdate_rangeTime Frame:7 daysenhanced_encryptionnoSafety Issue:
- To confirm the safety profile of a single dose of BAY94-9172(ZK6013443) in patients with probable AD and HVsdate_rangeTime Frame:7 daysenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1