Trial Condition(s):
Positron-Emission Tomography, Alzheimer's Disease
Evaluation of ZK 6032924 in probable Alzheimer's disease patients versus healthy volunteers and the radiation dosimetry of ZK 6032924 in healthy volunteers
Bayer Identifier:
91683
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset Huddinge Stockholm, Sweden, 141 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vrije Universiteit Medisch Centrum Amsterdam, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Visual analysis/description of the uptake and description of brain PET scansTimeframe: 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.Timeframe: Day of study tracer administration
Secondary Outcome
- Standard quantification variables derived from 3D PET imaging and brain modelingTimeframe: Day of study tracer administration
- Standard Safety Measurement:adverse event collectionTimeframe: Maximum time from Screening to Follow up are 37 days
- Standard Safety Measurement:electrocardiogramTimeframe: Maximum time from Screening to Follow up are 37 days
- Standard Safety Measurement:safety laboratoryTimeframe: Maximum time from Screening to Follow up are 37 days
- Standard Safety Measurement: vital signsTimeframe: Maximum time from Screening to Follow up are 37 days
Additional Information
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