Phase 2
N=109
Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
Down Syndrome · Amyloid Beta-protein
Bottom Line
View on ClinicalTrials.gov: NCT00928304 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome — 46.15; 100.00 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Florbetaben (BAY94-9172) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Lantheus Biosciences Ltd.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome |
46.15; 100.00 | — |
| SECONDARY Sensitivity Results in the Down Syndrome Age Subgroups |
23.81; 72.22 | — |
| SECONDARY Quantitative Parameters Standard Uptake Value Ratio |
1.396; 1.146; 1.525; 1.329; 1.350; 1.132 | — |
| SECONDARY Consistency Between Visual and Quantitative Efficacy |
1.566; 1.249; 1.146; 1.626; 1.438; 1.329 | — |
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 that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
Eligibility Criteria
Inclusion Criteria
Study participants were individuals with DS and healthy volunteers (HVs).
- Main inclusion criteria for individuals without DS
- >=21 and = 28
- Clinical Dementia Rating (CDR) of 0
- Main inclusion criteria for individuals with DS
- >= 40 years of age
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00928304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.