Phase 3
Completed N=218
Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology
Source: ClinicalTrials.gov NCT01020838 ↗Enrolled (actual)
218
Serious AEs
3.5%
Results posted
Mar 2015
Primary outcomePrimary: Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens — 77.36; 94.20; 85.71; 95.00 percentage of regions
Summary
To determine the sensitivity and specificity of the visual assessment of 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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens |
77.36; 94.20; 85.71; 95.00; 88.89; 86.36 | — |
| SECONDARY Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1). |
96.49; 85.00 | — |
| SECONDARY Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2). |
96.72; 94.44 | — |
| SECONDARY Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3). |
96.49; 85.00 | — |
| SECONDARY Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results. |
89; 82; 90; 91; 89; 90 | — |
| SECONDARY Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans |
1.296; 1.319; 1.537; 1.707; 1.625; 1.699 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01020838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.