Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012569-79 | EudraCT Number |
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To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Florbetaben (BAY94-9172) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetaben (BAY94-9172) | Drug | Single intravenous injection 1-5ml, 300 MBq (+/- 20%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens | The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as "normal" or "abnormal" depending on the presence or absence of regional tracer uptake in the respective region. "Normal" therefore meant absence of β-amyloid and "abnormal" presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was "β-amyloid present". Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was "β-amyloid not present". | 90-110 minutes post injection (PET image acquisition) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1). | Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining (SOT 1). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present". |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Piramal Imaging SA Study Director | Lantheus Biosciences Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun City | Arizona | 85351 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26823561 | Derived | Seibyl J, Catafau AM, Barthel H, Ishii K, Rowe CC, Leverenz JB, Ghetti B, Ironside JW, Takao M, Akatsu H, Murayama S, Bullich S, Mueller A, Koglin N, Schulz-Schaeffer WJ, Hoffmann A, Sabbagh MN, Stephens AW, Sabri O. Impact of Training Method on the Robustness of the Visual Assessment of 18F-Florbetaben PET Scans: Results from a Phase-3 Study. J Nucl Med. 2016 Jun;57(6):900-6. doi: 10.2967/jnumed.115.161927. Epub 2016 Jan 28. | |
| 25824567 |
Not provided
Not provided
Not provided
Subjects were screened at 15 study centers in Australia, Germany, France, Japan, and the U.S.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All patients enrolling into the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| 90-110 minutes post injection (PET image acquisition) |
| Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2). | Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present". | 90-110 minutes post injection (PET image acquisition) |
| Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3). | Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of β-amyloid according to CERAD Criteria (SOT 3). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present". | 90-110 minutes post injection (PET image acquisition) |
| Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results. | Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity. | 90-110 minutes post injection (PET image acquisition) |
| Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans | Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. | 90-110 minutes post injection (PET image acquisition) |
| Stanford |
| California |
| 94305 |
| United States |
| Tampa | Florida | 33616 | United States |
| Teaneck | New Jersey | 07666 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Dallas | Texas | 75390 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| Heidelberg | Victoria | 3084 | Australia |
| Lille | 59037 | France |
| Strasbourg | 67091 | France |
| Jülich | North Rhine-Westphalia | 52425 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Toyohashi | Aichi-ken | 440-0045 | Japan |
| Toyohashi | Aichi-ken | 441-8021 | Japan |
| Toyohashi | Aichi-ken | 441-8124 | Japan |
| Isesaki | Gunma | 372-0006 | Japan |
| Hamamatsu | Shizuoka | 432-8580 | Japan |
| Itabashi-ku | Tokyo | 173-0015 | Japan |
| Derived |
| Sabri O, Sabbagh MN, Seibyl J, Barthel H, Akatsu H, Ouchi Y, Senda K, Murayama S, Ishii K, Takao M, Beach TG, Rowe CC, Leverenz JB, Ghetti B, Ironside JW, Catafau AM, Stephens AW, Mueller A, Koglin N, Hoffmann A, Roth K, Reininger C, Schulz-Schaeffer WJ; Florbetaben Phase 3 Study Group. Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: phase 3 study. Alzheimers Dement. 2015 Aug;11(8):964-74. doi: 10.1016/j.jalz.2015.02.004. Epub 2015 Mar 28. |
| Safety Analysis Set |
|
| Interim Analysis Set (Primary Efficacy) |
|
| Final Analysis Set (Whole Brain) |
|
| First Annual Repeat Injection |
|
| Second Annual Repeat Injection |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants in the safety analysis set were treated with study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety Analysis Set | All study participants who received any amount of florbetaben were included in the safety analysis set. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||||||||
| Body weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Baseline clinical diagnosis | Number | 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 | Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens | The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as "normal" or "abnormal" depending on the presence or absence of regional tracer uptake in the respective region. "Normal" therefore meant absence of β-amyloid and "abnormal" presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was "β-amyloid present". Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was "β-amyloid not present". | All participants included in the Interim Analysis Set were included in this analysis. | Posted | Number | percentage of regions | 90-110 minutes post injection (PET image acquisition) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1). | Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining (SOT 1). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present". | Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining (SOT 1). | Posted | Number | 95% Confidence Interval | percentage of subjects | 90-110 minutes post injection (PET image acquisition) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2). | Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present". | Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral neuritic β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining and immunohistochemistry (SOT 2). | Posted | Number | 95% Confidence Interval | percentage of subjects | 90-110 minutes post injection (PET image acquisition) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3). | Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of β-amyloid according to CERAD Criteria (SOT 3). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present". | Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification according to CERAD Criteria (SOT 3). | Posted | Number | 95% Confidence Interval | percentage of subjects | 90-110 minutes post injection (PET image acquisition) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results. | Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity. | Sensitivity and Specificity of the subject level Composite SUVR with three different SOTs. | Posted | Number | percentage of subjects | 90-110 minutes post injection (PET image acquisition) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans | Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. | Posted | Mean | Standard Deviation | Standardized Uptake Value Ratio (SUVR) | 90-110 minutes post injection (PET image acquisition) |
|
All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
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 | Initial Drug Administration | Subjects with TEAEs within 7 days of the initial administration of florbetaben. | 12 | 216 | 48 | 216 | ||
| EG001 | 1st Repeat Drug Administration | Subjects with TEAEs within 7 days of the 1st repeat drug administration. | 0 | 91 | 22 | 91 | ||
| EG002 | 2nd Repeat Drug Administration | Subjects with TEAEs within 7 days of the 2nd repeat drug administration. | 0 | 34 | 14 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Frontotemporal dementia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dementia, Alzheimers' type | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colon cancer | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hepatic cancer metastatic | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Heat stroke | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Puncture site reaction | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Injection site hematoma | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Injection site hemorrhage | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vessel puncture site swelling | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juergen Hirschfeld | Piramal Imaging | 49 30 461 1246 15 | juergen.hirschfeld@piramal.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other dementia subject |
|
| Healthy volunteers |
|
| Healthy negative control |
|
| Occipital Cortex |
|
| Hippocampus |
|
| Anterior Cingulate Cortex |
|
| Posterior Cingulate Cortex |
|
| Cerebellar Cortex |
|
| For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read. The following hypothesis was formulated for specificity: H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity > 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8 | Specificity | 0.942 | 2-Sided | 95 | 0.886 | 0.998 | Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT | No | Superiority or Other |
|
|
|
|
|
|
| OG001 | Specificity of Subject Level Composite SUVR by SOT | The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Specificity of subject level composite SUVR by SOT for baseline scans and last available scans are reported. |
|
|
The analysis set consisted of data from 3 subjects with brain specimens available. |
|
|