Overview

This trial is active, not recruiting.

Condition alzheimer disease
Treatment florbetaben (bay94-9172)
Phase phase 3
Sponsor Piramal Imaging SA
Start date November 2009
End date September 2011
Trial size 216 participants
Trial identifier NCT01020838, 14595, 2009-012569-79

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
florbetaben (bay94-9172)
Single intravenous injection 1-5ml

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
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
To evaluate the safety and tolerability of a single dose of BAY94-9172
time frame: 8 days

Eligibility Criteria

Male or female participants at least 21 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Piramal Imaging SA.