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Trial record 8 of 15 for:    Florbetaben | "Amyloidosis"

Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

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ClinicalTrials.gov Identifier: NCT01138111
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Life Molecular Imaging SA

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Alzheimer Disease
Amyloid Beta-Protein
Intervention Drug: Florbetaben (BAY94-9172)
Enrollment 45
Recruitment Details A total of 71 patients were screened at one study center in Australia. The first subject's consent was obtained on 02 JUN 2008.
Pre-assignment Details 26 subjects were screen failures and did not have study drug administered.
Arm/Group Title MCI Subjects
Hide Arm/Group Description Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection of 300 megaBecqerels (MBq) florbetaben, at baseline, at 12 and 24 months
Period Title: Overall Study
Started 45
Completed 36
Not Completed 9
Reason Not Completed
Withdrawal by Subject             5
Adverse Event             1
Death             1
Lost to Follow-up             2
Arm/Group Title MCI Subjects
Hide Arm/Group Description Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
All enrolled subjects who received at least one florbetaben (BAY94-9172) injection
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  13.3%
>=65 years
39
  86.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
72.7  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
16
  35.6%
Male
29
  64.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 45 participants
45
1.Primary Outcome
Title Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
Hide Description Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)
Time Frame 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving study drug with PET scan data at the respective timepoint
Arm/Group Title Not Progressed to AD (Baseline) Progressed to AD (Baseline) Not Progressed to AD (12 Month) Progressed to AD (12 Month) Not Progressed to AD (24 Month) Progressed to AD (24 Month)
Hide Arm/Group Description:
Mean SUVR for the baseline PET scan in subjects who did not progress to AD during the study
Mean SUVR for the baseline PET scan in subjects who progressed to AD during the study
Mean SUVR for the 12 month PET scan in subjects who did not progress to AD during the study
Mean SUVR for the 12 month PET scan in subjects who progressed to AD during the study
Mean SUVR for the 24 month PET scan in subjects who did not progress to AD during the study
Mean SUVR for the 24 month PET scan in subjects who progressed to AD during the study
Overall Number of Participants Analyzed 26 19 24 17 22 14
Mean (Standard Deviation)
Unit of Measure: SUVR
1.430  (0.252) 1.726  (0.227) 1.442  (0.270) 1.738  (0.236) 1.439  (0.219) 1.796  (0.296)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Not Progressed to AD (Baseline), Progressed to AD (Baseline)
Comments The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Not Progressed to AD (12 Month), Progressed to AD (12 Month)
Comments The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Not Progressed to AD (24 Month), Progressed to AD (24 Month)
Comments The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4
Hide Description This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress.
Time Frame 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving study drug
Arm/Group Title Not Progressed to AD (Baseline) Progressed to AD (Baseline) Not Progressed to AD (12 Month) Progressed to AD (12 Month) Not Progressed to AD (24 Month) Progressed to AD (24 Month)
Hide Arm/Group Description:
Results from baseline scan for participants with no progression to AD within 2 years after baseline scan
Results from baseline scan for participants with progression from MCI to AD within 2 years after baseline scan.
Results from 12 month scan for participants with no progression to AD within 2 years after baseline scan.
Results from 12 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
Results from 24 month scan for participants with no progression to AD within 2 years after baseline scan.
Results from 24 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
Overall Number of Participants Analyzed 26 19 24 18 22 14
Measure Type: Number
Unit of Measure: participants
Number with Normal Scan 17 2 15 2 12 1
Number with Abnormal Scan 9 17 9 16 10 13
3.Secondary Outcome
Title Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress
Hide Description At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader’s evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period.
Time Frame 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with PET data at the referenced study time point
Arm/Group Title Not Progressed to AD (Baseline) Progressed to AD (Baseline) Not Progressed to AD (12 Month) Progressed to AD (12 Month) Not Progressed to AD (24 Month) Progressed to AD (24 Month)
Hide Arm/Group Description:
Baseline PET scan results for subjects who did not progress to AD through the end of the two year follow up period
Baseline PET scan results for subjects who progressed to AD within the two year follow up period
12 month PET scan results for subjects who did not progress to AD through the end of the two year follow up period
12 month PET scan results for subjects who progressed to AD within the two year follow up period
24 month scan results for subjects who did not progress to AD through the end of the two year follow up period
24 month PET scan results for subjects who progressed to AD within the two year follow up period
Overall Number of Participants Analyzed 26 19 24 17 22 14
Measure Type: Number
Unit of Measure: participants
45 min normal PET assessment 15 2 16 0 14 0
45 min abnormal PET assessment 11 17 8 17 8 14
90 min normal PET assessment 16 0 14 1 14 2
90 min abnormal PET assessment 10 19 10 16 8 12
4.Secondary Outcome
Title Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress
Hide Description

Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive.

For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point.

Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point.

PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period.

NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period.

Time Frame 2 scanning periods post injection to be evaluated at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with PET data at the referenced study time point
Arm/Group Title Baseline 45 Min Baseline 90 Min 12 Month 45 Min 12 Month 90 Min 24 Month 45 Min 24 Month 90 Min
Hide Arm/Group Description:
Baseline PET scan at 45 min post-injection
Baseline PET scan at 90 min post-injection
12 month PET scan at 45 min post-injection
12 month PET scan at 90 min post-injection
24 month PET scan at 45 min post-injection
24 month PET scan at 90 min post-injection
Overall Number of Participants Analyzed 45 45 41 41 36 36
Measure Type: Number
Unit of Measure: percentage of subjects
Sensitivity 89.47 100.00 100.00 94.12 100.00 85.71
Specificity 57.69 61.54 66.67 58.33 63.64 63.64
Positive Predictive value 60.71 65.52 68.00 61.54 63.64 60.00
Negative predictive value 88.24 100.00 100.00 93.33 100.00 87.50
Time Frame AEs were defined for the period starting immediately after injection and up to the 7 day follow-up (baseline, 12 month, and 24 month follow-up visit.)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MCI Subjects (Initial Drug Administration) MCI Subjects (1st Repeat Drug Administration) MCI Subjects (2nd Repeat Drug Administration)
Hide Arm/Group Description Subjects with AEs following the initial administration of florbetaben (BAY94-9172) at the baseline visit Subjects with AEs following the second administration of florbetaben (BAY94-9172) at the 12 month visit Subjects with AEs following the third administration of florbetaben (BAY94-9172) at the 24 month visit
All-Cause Mortality
MCI Subjects (Initial Drug Administration) MCI Subjects (1st Repeat Drug Administration) MCI Subjects (2nd Repeat Drug Administration)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MCI Subjects (Initial Drug Administration) MCI Subjects (1st Repeat Drug Administration) MCI Subjects (2nd Repeat Drug Administration)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/41 (0.00%)      2/36 (5.56%)    
Metabolism and nutrition disorders       
Hypokalaemia  1  0/45 (0.00%)  0 0/41 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders       
Hemiparesis  1  0/45 (0.00%)  0 0/41 (0.00%)  0 1/36 (2.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MCI Subjects (Initial Drug Administration) MCI Subjects (1st Repeat Drug Administration) MCI Subjects (2nd Repeat Drug Administration)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/45 (28.89%)      3/41 (7.32%)      2/36 (5.56%)    
General disorders       
Catheter site haemorrhage  1  3/45 (6.67%)  3 0/41 (0.00%)  0 0/36 (0.00%)  0
Injection site pain  1  9/45 (20.00%)  9 0/41 (0.00%)  0 2/36 (5.56%)  2
Injury, poisoning and procedural complications       
Contusion  1  0/45 (0.00%)  0 3/41 (7.32%)  3 0/36 (0.00%)  0
Nervous system disorders       
Burning sensation  1  3/45 (6.67%)  3 0/41 (0.00%)  0 0/36 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Juergen Hirschfeld, Senior Director Regulatory Affairs
Organization: Piramal Imaging
Phone: +49 30 461 1246 15
Responsible Party: Life Molecular Imaging SA
ClinicalTrials.gov Identifier: NCT01138111     History of Changes
Other Study ID Numbers: 312043
First Submitted: April 1, 2010
First Posted: June 7, 2010
Results First Submitted: January 10, 2014
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014