Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| i3 Statprobe | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 flutemetamol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F] Flutemetamol | Drug | All subjects will receive an intravenous (IV) dose of [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels (MBq). |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region. | Post-contrast administration |
| Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228. | Post-contrast administration |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid. | Post-contrast Administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kim A Mansfield, MS | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Flutemetamol Injection | [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Flutemetamol Injection | [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq). |
| 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 Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region. | Posted | Number | Standard Uptake Value Ratio (SUVR) | Post-contrast administration |
|
Not provided
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 | Flutemetamol Injection | [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Pressure Increase | Investigations | MedDRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Sherwin, MD | GE Healthcare | 1-609-514-6820 | paulsherwin@ge.com |
Not provided
| ID | Term |
|---|---|
| D006850 | Hydrocephalus, Normal Pressure |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581552 | flutemetamol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Subject 201-0002 | [18F]flutemetamol Injection-less than 10µg of flutemetamol. |
| OG002 | Subject 201-0003 | [18F]flutemetamol Injection-less than 10µg of flutemetamol. |
| OG003 | Subject 201-0004 | [18F]flutemetamol Injection-less than 10µg of flutemetamol. |
| OG004 | Subject 201-0005 | [18F]flutemetamol Injection-less than 10µg of flutemetamol. |
| OG005 | Subject 201-0006 | [18F]flutemetamol Injection-less than 10µg of flutemetamol. |
| OG006 | Subject 201-0007 | [18F]flutemetamol Injection-less than 10µg of flutemetamol. |
|
|
| Primary | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228. | Posted | Number | Percent plaque area | Post-contrast administration |
|
|
|
| Secondary | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid. | Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid. | Posted | Number | Percentage of Plaque | Post-contrast Administration |
|
|
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| Blood Glucose Decrease | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
Not provided
| D003704 |
| Dementia |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Subject-201-0004 |
|
| Subject-201-0005 |
|
| Subject-201-0006 |
|
| Subject-201-0007 |
|
| Regression, Linear |
| 0.268 |
| R² |
| 0.482 |
| Yes |
| Non-Inferiority or Equivalence |
The level of association between SUVR and the amyloid levels was analyzed using a regression model. |
| Composite Region | Regression, Linear | 0.099 | R² | 0.685 | Yes | Non-Inferiority or Equivalence | The level of association between SUVR and the amyloid levels was analyzed using a regression model. |