Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetaben (BAY94-9172) | Drug | single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg | Victoria | 3084 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33773598 | Derived | Bullich S, Roe-Vellve N, Marquie M, Landau SM, Barthel H, Villemagne VL, Sanabria A, Tartari JP, Sotolongo-Grau O, Dore V, Koglin N, Muller A, Perrotin A, Jovalekic A, De Santi S, Tarraga L, Stephens AW, Rowe CC, Sabri O, Seibyl JP, Boada M. Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6. | |
| 24970906 |
Not provided
Not provided
26 subjects were screen failures and did not have study drug administered.
A total of 71 patients were screened at one study center in Australia. The first subject's consent was obtained on 02 JUN 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MCI Subjects | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects who received at least one florbetaben (BAY94-9172) injection
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MCI Subjects | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | All subjects receiving study drug with PET scan data at the respective timepoint | Posted | Mean | Standard Deviation | SUVR | 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months |
|
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.)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MCI Subjects (Initial Drug Administration) | Subjects with AEs following the initial administration of florbetaben (BAY94-9172) at the baseline visit |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site haemorrhage | General disorders | MedDra 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juergen Hirschfeld, Senior Director Regulatory Affairs | Piramal Imaging | +49 30 461 1246 15 | juergen.hirschfeld@piramal.com |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 2 scanning periods post injection to be evaluated at baseline |
| Derived |
| Ong KT, Villemagne VL, Bahar-Fuchs A, Lamb F, Langdon N, Catafau AM, Stephens AW, Seibyl J, Dinkelborg LM, Reininger CB, Putz B, Rohde B, Masters CL, Rowe CC. Abeta imaging with 18F-florbetaben in prodromal Alzheimer's disease: a prospective outcome study. J Neurol Neurosurg Psychiatry. 2015 Apr;86(4):431-6. doi: 10.1136/jnnp-2014-308094. Epub 2014 Jun 26. |
| Lost to Follow-up |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Mean SUVR for the baseline PET scan in subjects who progressed to AD during the study
| OG002 | Not Progressed to AD (12 Month) | Mean SUVR for the 12 month PET scan in subjects who did not progress to AD during the study |
| OG003 | Progressed to AD (12 Month) | Mean SUVR for the 12 month PET scan in subjects who progressed to AD during the study |
| OG004 | Not Progressed to AD (24 Month) | Mean SUVR for the 24 month PET scan in subjects who did not progress to AD during the study |
| OG005 | Progressed to AD (24 Month) | Mean SUVR for the 24 month PET scan in subjects who progressed to AD during the study |
|
|
|
| Secondary | 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. | All subjects receiving study drug | Posted | Number | participants | 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months |
|
|
|
| Secondary | 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. | All subjects with PET data at the referenced study time point | Posted | Number | participants | 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months |
|
|
|
| Secondary | 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. | All subjects with PET data at the referenced study time point | Posted | Number | percentage of subjects | 2 scanning periods post injection to be evaluated at baseline |
|
|
|
| 0 |
| 45 |
| 13 |
| 45 |
| EG001 | MCI Subjects (1st Repeat Drug Administration) | Subjects with AEs following the second administration of florbetaben (BAY94-9172) at the 12 month visit | 0 | 41 | 3 | 41 |
| EG002 | MCI Subjects (2nd Repeat Drug Administration) | Subjects with AEs following the third administration of florbetaben (BAY94-9172) at the 24 month visit | 2 | 36 | 2 | 36 |
| Hemiparesis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Number with Abnormal Scan |
|
| 45 min abnormal PET assessment |
|
| 90 min normal PET assessment |
|
| 90 min abnormal PET assessment |
|
| Specificity |
|
| Positive Predictive value |
|
| Negative predictive value |
|