Status:
COMPLETED
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
Lead Sponsor:
Life Molecular Imaging SA
Conditions:
Alzheimer Disease
Amyloid Beta-Protein
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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 Dementia with Lewy Bodies (DLB) or Vascular Dementia (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
- 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 milli Sieverts (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 cerebro-spinal fluid (CSF) circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
- Has an inflammatory or infectious central nervous system (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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT00750282
Start Date
August 1 2008
End Date
November 1 2010
Last Update
July 24 2014
Active Locations (23)
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1
Sun City, Arizona, United States, 85351
2
Stanford, California, United States, 94305
3
New Haven, Connecticut, United States, 06510
4
New York, New York, United States, 10016