Trial Condition(s):

Alzheimer Disease, Amyloid beta-protein

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

Bayer Identifier:

91708

ClinicalTrials.gov Identifier:

NCT00750282

EudraCT Number:

2007-002256-42

Study Completed

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

Inclusion Criteria
- Each subject / Healthy volunteer (HV) who meets the following criteria will be eligible for enrollment into the study:
 -- Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60; or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
 -- Has at least 6 years of education
 -- Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures
 -- Possesses a general health that permits adequate compliance with all study procedures
 -- The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study
 -- Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
 - Inclusion criteria for HV only:
 -- Has no evidence of cognitive impairment
 -- Has MRI brain scan that has been judged as "normal" (age- appropriate)
 - Inclusion criteria for patients with AD only:
 -- Presents with positive assessment for dementia of Alzheimer's type
 -- Does not fulfill the criteria DLB or VaD
 -- MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease
 -- Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Exclusion Criteria
- Has any contraindication to MRI examination scan
 - Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
 - Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
 - is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
 - Has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
 - Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
 - 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 any radiopharmaceutical
 - Has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
 - Has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
 - Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
 - Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
 - Has a history of alcohol or drug abuse
 - Has history of severe persistent depression

Trial Summary

Enrollment Goal
422
Trial Dates
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Phase
2
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

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Universität Erlangen-Nürnberg

Erlangen, Germany, 91054

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Completed
 
Locations

Forschungszentrum Jülich GmbH

Jülich, Germany, 52425

Status
Completed
 
Locations

Columbia University

New York, United States, 10032

Status
Completed
 
Locations

Institute for Neurodegenerative Disorders

New Haven, United States, 06510

Status
Completed
 
Locations

New York University School of Medicine

New York, United States, 10016

Status
Completed
 
Locations

Montefiore Medical Center

Bronx, United States, 10461

Status
Completed
 
Locations

Butler Hospital

Providence, United States, 02906

Status
Completed
 
Locations

Nippon Medical School Hospital

Bunkyo-ku, Japan, 113-8603

Status
Completed
 
Locations

Austin and Repatriation Centre

Heidelberg, Australia, 3084

Status
Completed
 
Locations

Westmead Hospital

Westmead, Australia, 2145

Status
Completed
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 81377

Status
Completed
 
Locations

HELIOS Klinikum Berlin - Buch

Berlin, Germany, 13125

Status
Completed
 
Locations

Yale University School of Medicine

New Haven, United States, 06510

Status
Completed
 
Locations

Banner Sun Health Research Institute

Sun City, United States, 85351

Status
Completed
 
Locations

Stanford Hospital & Clinics

Stanford, United States, 94305

Status
Completed
 
Locations

Kobe University Hospital

Kobe, Japan, 650-0017

Status
Completed
 
Locations

Institute of Biomedical Research and Innovation

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 

Trial Design