Status:
COMPLETED
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients
Lead Sponsor:
Life Molecular Imaging SA
Conditions:
Alzheimer Disease
Amyloid Beta-Protein
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Al...
Eligibility Criteria
Inclusion
- Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss.
- Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years.
- Able to give written informed consent.
- Age \>/= 60 years of age
- \>/= 7 years of education
Exclusion
- Mini mental state examination (MMSE) score \< 24 at baseline
- Clinical dementia rating (CDR) score \> 0.5 at baseline
- Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics)
- Existing or history of cancer
- History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion
- Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder
- Contraindications to MRI (Magnetic resonance imaging)
- Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression
- History of severe anaphylactic reaction or high risk of allergic reaction to drugs
- Patient has received another investigational drug in the preceding 14 days
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01138111
Start Date
June 1 2008
End Date
December 1 2011
Last Update
June 25 2014
Active Locations (1)
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1
Heidelberg, Victoria, Australia, 3084