Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
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|ClinicalTrials.gov Identifier: NCT00928304|
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : January 28, 2014
Last Update Posted : March 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome Amyloid Beta-protein||Drug: Florbetaben (BAY94-9172)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Non-Randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection of Cerebral ß-Amyloid in Individuals With Down Syndrome Compared to Individuals Without Down Syndrome|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
|Experimental: Florbetaben (BAY94-9172)||
Drug: Florbetaben (BAY94-9172)
300 megabecquerels (MBq) as single IV injection of 2 to 10 mL
- Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome [ Time Frame: 100-120 min ]The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.
- Sensitivity Results in the Down Syndrome Age Subgroups [ Time Frame: 100 - 120 min ]The majority read sensitivity (percentage of DS subjects positive for cerebral beta-amyloid by majority read) was computed for the group of DS subjects with age equal to or below the median age (DS-young) and for DS subjects with age above the median age (DS-old). The median age was 46 yrs, with 3 subjects being exactly 46 yrs old. As defined, these subjects were assigned to the DS-young group.
- Quantitative Parameters Standard Uptake Value Ratio [ Time Frame: 100 - 120 min p.i. ]The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.
- Consistency Between Visual and Quantitative Efficacy [ Time Frame: 100 - 120 min ]For a comparison of the results of the visual assessment with the quantitative assessment, descriptive Standardized Uptake Value Ratio (SUVR) statistics were computed separately for DS subjects with an abnormal/normal majority read of the PET scan (DS-PET+/DS-PET-). The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928304
|United States, Arizona|
|Sun City, Arizona, United States, 85351|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510|
|Study Director:||Bayer Study Director||Bayer|