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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lantheus Biosciences Ltd.
Age
55–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
* Has no evidence of cognitive impairment
* Has MRI brain scan that has been judged as "normal" (age- appropriate)
* 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
You may not be if
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)
