Status:
COMPLETED
Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
Lead Sponsor:
Life Molecular Imaging SA
Conditions:
Down Syndrome
Amyloid Beta-protein
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given t...
Eligibility Criteria
Inclusion
- Study participants were individuals with DS and healthy volunteers (HVs).
- Main inclusion criteria for individuals without DS
- \>=21 and \<= 40 years of age
- Mini-Mental State Examination (MMSE) \>= 28
- Clinical Dementia Rating (CDR) of 0
- Main inclusion criteria for individuals with DS
- \>= 40 years of age
Exclusion
- Main exclusion criteria for both groups
- Unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00928304
Start Date
June 1 2009
End Date
January 1 2011
Last Update
March 5 2014
Active Locations (2)
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1
Sun City, Arizona, United States, 85351
2
New Haven, Connecticut, United States, 06510