Overview

Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
All
Summary
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bayer
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