Clinical trial NCT01035164: Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers
Official title: Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq (6.75 mCi) ZK 6032924 (18F-FEDAA1106) for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimer's Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 185 MBq (5 mCi) ZK 6032924 in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Positron-Emission Tomography
Alzheimer's Disease
Keywords: Alzheimer's Disease
Diagnostic Imaging
Neuroinflammation
PET Diagnosis
PET Tracer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-12-18
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analysis/description of the uptake and description of brain PET scans
timeFrame: Day of study tracer administration
measure: 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.
timeFrame: Day of study tracer administration
Secondary outcomes:
measure: Standard quantification variables derived from 3D PET imaging and brain modeling
timeFrame: Day of study tracer administration
measure: Standard Safety Measurement:adverse event collection
timeFrame: Maximum time from Screening to Follow up are 37 days
measure: Standard Safety Measurement:electrocardiogram
timeFrame: Maximum time from Screening to Follow up are 37 days
measure: Standard Safety Measurement:safety laboratory
timeFrame: Maximum time from Screening to Follow up are 37 days
measure: Standard Safety Measurement: vital signs
timeFrame: Maximum time from Screening to Follow up are 37 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: