A Phase 1 interventional study of Florbetaben (BAY94-9172) in Alzheimer Disease and Amyloid Beta-Protein, sponsored by Lantheus Biosciences Ltd.. Completed at 1 site in Australia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by Lantheus Biosciences Ltd. (part of Lantheus Holdings, Inc.) · Phase 1, Interventional, and Diagnostic
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 Alzheimer's disease (AD) from those with MCI not progressing to AD.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 45 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Lantheus Biosciences Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
First submitted before Lantheus Biosciences Ltd. became part of Lantheus Holdings, Inc..
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Drug: Florbetaben (BAY94-9172)
single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
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
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
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
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
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
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
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
A total of 71 patients were screened at one study center in Australia. The first subject's consent was obtained on 02 JUN 2008.
| Milestone | MCI Subjects |
|---|---|
| Started | 45 |
| Completed | 36 |
| Not completed | 9 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 2 |
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)
| SUVR | 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) |
|---|---|---|---|---|---|---|
| Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake | 1.430 ± 0.252 | 1.726 ± 0.227 | 1.442 ± 0.270 | 1.738 ± 0.236 | 1.439 ± 0.219 | 1.796 ± 0.296 |
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.
| participants | 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) |
|---|---|---|---|---|---|---|
| Number with Normal Scan | 17 | 2 | 15 | 2 | 12 | 1 |
| Number with Abnormal Scan | 9 | 17 | 9 | 16 | 10 | 13 |
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.
| participants | 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) |
|---|---|---|---|---|---|---|
| 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 |
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.
| percentage of subjects | Baseline 45 Min | Baseline 90 Min | 12 Month 45 Min | 12 Month 90 Min | 24 Month 45 Min | 24 Month 90 Min |
|---|---|---|---|---|---|---|
| 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 |
Collected over 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.). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCI Subjects (Initial Drug Administration) | — | 0/45 (0%) | 13/45 (28.9%) |
| MCI Subjects (1st Repeat Drug Administration) | — | 0/41 (0%) | 3/41 (7.3%) |
| MCI Subjects (2nd Repeat Drug Administration) | — | 2/36 (5.6%) | 2/36 (5.6%) |
| Event | MCI Subjects (Initial Drug Administration) | MCI Subjects (1st Repeat Drug Administration) | MCI Subjects (2nd Repeat Drug Administration) |
|---|---|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 0/45 | 0/41 | 1/36 |
| HemiparesisNervous system disorders | 0/45 | 0/41 | 1/36 |
| Event | MCI Subjects (Initial Drug Administration) | MCI Subjects (1st Repeat Drug Administration) | MCI Subjects (2nd Repeat Drug Administration) |
|---|---|---|---|
| Injection site painGeneral disorders | 9/45 | 0/41 | 2/36 |
| ContusionInjury, poisoning and procedural complications | 0/45 | 3/41 | 0/36 |
| Catheter site haemorrhageGeneral disorders | 3/45 | 0/41 | 0/36 |
| Burning sensationNervous system disorders | 3/45 | 0/41 | 0/36 |
All enrolled subjects who received at least one florbetaben (BAY94-9172) injection
| Age, Categorical(Participants) | MCI Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 39 |
| Age, Continuous(years) | MCI Subjects |
|---|---|
| Mean | 72.7 ± 6.5 |
| Sex: Female, Male(Participants) | MCI Subjects |
|---|---|
| Female | 16 |
| Male | 29 |
| Region of Enrollment(participants) | MCI Subjects |
|---|---|
| Australia | 45 |
The record gives a start of Jun 2008, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 2 years 6 months after primary completion.
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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Florbetaben f-18