Back to resultsEvaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
Primary Purpose
Diagnostic Imaging
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BAY1006578
BAY1006578
BAY1006578
Sponsored by
About this trial
This is an interventional diagnostic trial for Diagnostic Imaging focused on measuring Alzheimer's disease, Diagnostic imaging, PET diagnosis, PET tracer
Eligibility Criteria
Inclusion Criteria:
All:
- Males or females aged >/- 50 years
- Participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
Healthy volunteers for brain imaging:
- Mini-Mental State Examination (MMSE) score of >/= 28
- CDR score of zero (0)
Patients for brain imaging:
- Patient fulfills Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's Disease (AD), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
- Patient has mild to moderate dementia with a dementia score of >/= 20 on the Mini Mental State Examination (MMSE) / with a Clinical Dementia Rating score of 1 or 2 (CDR)
Exclusion Criteria:
All:
- No significant disease or drug use
Patients for brain imaging:
- Evidence for any other neurological or psychiatric disease
Healthy volunteers for brain imaging:
- Family history of Alzheimer's Disease in a 1st or 2nd degree relative under 75 years of age
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
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
Secondary Outcome Measures
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by visual analysis and by standard parameters (e.g. Standardized Uptake Values=SUV)
Electrocardiogram (ECG)
Blood pressure
Adverse events collection
Full Information
NCT ID
NCT01153607
First Posted
April 23, 2010
Last Updated
January 18, 2013
Sponsor
Life Molecular Imaging SA
1. Study Identification
Unique Protocol Identification Number
NCT01153607
Brief Title
Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
Official Title
Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of BAY1006578 for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimers Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of BAY1006578 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Molecular Imaging SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic potential in probable Alzheimer Disease patients versus healthy volunteers and radiation dosimetry in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Imaging
Keywords
Alzheimer's disease, Diagnostic imaging, 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
24 (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)
BAY1006578
Intervention Description
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
Intervention Type
Drug
Intervention Name(s)
BAY1006578
Intervention Description
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
Intervention Type
Drug
Intervention Name(s)
BAY1006578
Intervention Description
Healthy volunteers for whole body imaging: Single intravenous bolus injection of 190 MBq BAY1006578, whole body PET for evaluation of effective dose, kinetics of BAY1006578 in blood
Primary Outcome Measure Information:
Title
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
Time Frame
Day 1 - day of study tracer administration
Secondary Outcome Measure Information:
Title
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by visual analysis and by standard parameters (e.g. Standardized Uptake Values=SUV)
Time Frame
Day 1 - day of study tracer administration
Title
Electrocardiogram (ECG)
Time Frame
At least once within 8 days after treatment
Title
Blood pressure
Time Frame
At least 2 times within 8 days after treatment
Title
Adverse events collection
Time Frame
Continuously and for a maximum of 28 days after end of observation phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All:
Males or females aged >/- 50 years
Participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
Healthy volunteers for brain imaging:
Mini-Mental State Examination (MMSE) score of >/= 28
CDR score of zero (0)
Patients for brain imaging:
Patient fulfills Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's Disease (AD), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
Patient has mild to moderate dementia with a dementia score of >/= 20 on the Mini Mental State Examination (MMSE) / with a Clinical Dementia Rating score of 1 or 2 (CDR)
Exclusion Criteria:
All:
No significant disease or drug use
Patients for brain imaging:
Evidence for any other neurological or psychiatric disease
Healthy volunteers for brain imaging:
Family history of Alzheimer's Disease in a 1st or 2nd degree relative under 75 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Turku
ZIP/Postal Code
FIN-20520
Country
Finland
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
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