Back to resultsEvaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers
Primary Purpose
Positron-Emission Tomography, Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
F-18 FEDAA1106 (BAY85-8101)
F-18 FEDAA1106 (BAY85-8101)
F-18 FEDAA1106 (BAY85-8101)
Sponsored by
About this trial
This is an interventional diagnostic trial for Positron-Emission Tomography focused on measuring Alzheimer's Disease, Diagnostic Imaging, Neuroinflammation, PET Diagnosis, PET Tracer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
Visual analysis/description of the uptake and description of brain PET scans
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.
Secondary Outcome Measures
Standard quantification variables derived from 3D PET imaging and brain modeling
Standard Safety Measurement:adverse event collection
Standard Safety Measurement:electrocardiogram
Standard Safety Measurement:safety laboratory
Standard Safety Measurement: vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01035164
Brief Title
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
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positron-Emission Tomography, Alzheimer's Disease
Keywords
Alzheimer's Disease, Diagnostic Imaging, Neuroinflammation, PET Diagnosis, PET Tracer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
F-18 FEDAA1106 (BAY85-8101)
Intervention Description
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
Intervention Type
Drug
Intervention Name(s)
F-18 FEDAA1106 (BAY85-8101)
Intervention Description
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
Intervention Type
Drug
Intervention Name(s)
F-18 FEDAA1106 (BAY85-8101)
Intervention Description
Healthy volunteers for whole body imaging: Single intravenous bolus injection of 185 MBq BAY85-8101, whole body PET for evaluation of effective dose, kinetics of BAY85-8101 in blood
Primary Outcome Measure Information:
Title
Visual analysis/description of the uptake and description of brain PET scans
Time Frame
Day of study tracer administration
Title
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.
Time Frame
Day of study tracer administration
Secondary Outcome Measure Information:
Title
Standard quantification variables derived from 3D PET imaging and brain modeling
Time Frame
Day of study tracer administration
Title
Standard Safety Measurement:adverse event collection
Time Frame
Maximum time from Screening to Follow up are 37 days
Title
Standard Safety Measurement:electrocardiogram
Time Frame
Maximum time from Screening to Follow up are 37 days
Title
Standard Safety Measurement:safety laboratory
Time Frame
Maximum time from Screening to Follow up are 37 days
Title
Standard Safety Measurement: vital signs
Time Frame
Maximum time from Screening to Follow up are 37 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers
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