Status:
COMPLETED
Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
Lead Sponsor:
Life Molecular Imaging SA
Conditions:
Diagnostic Imaging
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01153607
Start Date
June 1 2010
End Date
October 1 2011
Last Update
January 21 2013
Active Locations (2)
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1
Turku, Finland, FIN-20520
2
Stockholm, Sweden, 141 86