Trial Condition(s):

Alzheimer Disease

Phase III study of Florbetaben (BAY94-9172) PET imaging for detection/exclusion of cerebral β-amyloid compared to histopathology

Bayer Identifier:

14595

ClinicalTrials.gov Identifier:

NCT01020838

EudraCT Number:

2009-012569-79

Recruitment Complete

Trial 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

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)

Trial Summary

Enrollment Goal
216
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
NEURACEQ (Florbetaben F-18, BAY94-9172)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Active, not recruiting
 
Locations

Banner Sun Health Research Institute

Sun City, United States, 85351

Status
Active, not recruiting
 
Locations

Holy Name Medical Center

Teaneck, United States, 07666

Status
Active, not recruiting
 
Locations

Stanford University

Stanford, United States, 94305

Status
Active, not recruiting
 
Locations

University of South Florida

Tampa, United States, 33616

Status
Active, not recruiting
 
Locations

Hopital Roger Salengro - Lille

LILLE, France, 59037

Status
Active, not recruiting
 
Locations

Tokyo Metropolitan Geriatric Hospital

Itabashi-ku, Japan, 173-0015

Status
Terminated
 
Locations

Fukushimura Hospital

Toyohashi, Japan, 441-8124

Status
Active, not recruiting
 
Locations

Narita Memorial Hospital

Toyohashi, Japan, 441-8029

Status
Terminated
 
Locations

Austin and Repatriation Centre

Heidelberg, Australia, 3084

Status
Active, not recruiting
 
Locations

Forschungszentrum Jülich GmbH

Jülich, Germany, 52425

Status
Active, not recruiting
 
Locations

University of Texas Health Science Center

San Antonio, United States, 78229

Status
Active, not recruiting
 
Locations

Tokyo Metropolitan Geriatric Hospital

Itabashi-ku, Japan, 173-0015

Status
Active, not recruiting
 
Locations

Mihara Memorial Hospital

Isezaki, Japan, 372-0006

Status
Active, not recruiting
 
Locations

Hamamatsu Medical Center

Hamamatsu, Japan, 432-8580

Status
Terminated
 
Locations

University of Texas Southwestern Medical Center

Dallas, United States, 75390

Status
Active, not recruiting
 
Locations

Hospital of the University of Pennsylvania

Philadelphia, United States, 19104

Status
Active, not recruiting
 
Locations

Koseikai Hospital

Toyohashi, Japan, 440-0045

Status
Terminated
 
Locations

The Methodist Hospital System

Houston, United States, 77030

Status
Terminated
 
Locations

Hôpital Civil - Strasbourg

STRASBOURG, France, 67091

Status
Active, not recruiting
 

Trial Design