Alzheimer's Disease, Positron-Emission Tomography
Conditions
Keywords
Alzheimer's Disease, Diagnostic Imaging, Neuroinflammation, PET Diagnosis, PET Tracer
Brief summary
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
Interventions
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients for brain imaging:- patient and designee capable of giving fully informed consent in writing- patient fulfils DSM-IV and NINCDS-ADRDA criteria for probable Alzheimer's disease. Other forms of dementia excluded- males or postmenopausal females aged \>/= 50 yearsHealthy volunteers for brain imaging: - able to give fully informed consent in writing- absence of any sign of dementia/cognitive impairment in neuropsychological examinations- males or postmenopausal females aged \>/= 50 years Healthy volunteers for whole body imaging:- able to give fully informed consent in writing - males or postmenopausal females aged \>/= 60 years - no significant disease or drug use
Exclusion criteria
For all healthy volunteers and patients:- Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analysis/description of the uptake and description of brain PET scans | Day of study tracer administration |
| Standardized uptake value (SUV) in various cerebral regions/volumes of interest (ROI/VOI) assumed and found to be involved in the pathophysiology of Alzheimer's disease. | Day of study tracer administration |
Secondary
| Measure | Time frame |
|---|---|
| Standard Safety Measurement:electrocardiogram | Maximum time from Screening to Follow up are 37 days |
| Standard quantification variables derived from 3D PET imaging and brain modeling | Day of study tracer administration |
| Standard Safety Measurement: vital signs | Maximum time from Screening to Follow up are 37 days |
| Standard Safety Measurement:safety laboratory | Maximum time from Screening to Follow up are 37 days |
| Standard Safety Measurement:adverse event collection | Maximum time from Screening to Follow up are 37 days |
Countries
Netherlands, Sweden
Outcome results
None listed