Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology
This study is ongoing, but not recruiting participants.
Sponsor:
Piramal Imaging SA
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01020838
First received: November 16, 2009
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Florbetaben (BAY94-9172) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | An Open-label, Non-randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) Imaging for Detection/Exclusion of Cerebral Beta-amyloid When Compared to Postmortem Histopathology |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Piramal Imaging SA:
Primary Outcome Measures:
- 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 specimens [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 deposition [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
- 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 truth [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
- 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 diagnosis [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
- To evaluate the safety and tolerability of a single dose of BAY94-9172 [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 216 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | August 2014 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Florbetaben (BAY94-9172)
Single intravenous injection 1-5ml
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Females, no child-bearing potential or negative urine pregnancy test on day of BAY94-9172 injection
- 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 severe cerebral macrovascular (ie, multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020838
Locations
| United States, Arizona | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Tampa, Florida, United States, 33616 | |
| United States, New Jersey | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Dallas, Texas, United States, 75390 | |
| Houston, Texas, United States, 77030 | |
| San Antonio, Texas, United States, 78229 | |
| Australia, Victoria | |
| Heidelberg, Victoria, Australia, 3084 | |
| France | |
| Lille, France, 59037 | |
| Strasbourg, France, 67091 | |
| Germany | |
| Jülich, Nordrhein-Westfalen, Germany, 52425 | |
| Leipzig, Sachsen, Germany, 04103 | |
| Japan | |
| Toyohashi, Aichi, Japan, 441-8124 | |
| Toyohashi, Aichi, Japan, 441-8021 | |
| Toyohashi, Aichi, Japan, 440-0045 | |
| Isezaki, Gunma, Japan, 372-0006 | |
| Hamamatsu, Shizuoka, Japan, 432-8580 | |
| Itabashi-ku, Tokyo, Japan, 173-0015 | |
Sponsors and Collaborators
Piramal Imaging SA
Investigators
| Study Director: | Piramal Imaging SA Study Director | Piramal Imaging SA |
More Information
Additional Information:
No publications provided
| Responsible Party: | Piramal Imaging SA |
| ClinicalTrials.gov Identifier: | NCT01020838 History of Changes |
| Other Study ID Numbers: | 14595, 2009-012569-79 |
| Study First Received: | November 16, 2009 |
| Last Updated: | May 9, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Japan: Pharmaceuticals and Medical Devices Agency United States: Food and Drug Administration |
Keywords provided by Piramal Imaging SA:
|
Florbetaben Amyloid beta-protein Alzheimer's disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013