Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Flutemetamol · 6 trials · 5 indications
Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.
Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.
The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging. The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).
A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.
Visual Interpretation of the PET scan by independent readers. Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1. As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases. Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included).
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.
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.
The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant's brain image and the participant's clinical diagnosis by 5 non-Japanese readers, who classified each participant's images as either normal or abnormal (raised) Flutemetanol F 18 uptake.
The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant's brain image and the participant's clinical diagnosis by 5 Japanese readers, who classified each participant's images as either normal or abnormal (raised) Flutemetanol F 18 uptake.
| Arm | Type | Description |
|---|---|---|
| [18F]Flutemetamol | EXPERIMENTAL | - |
| (18F) Flutemetamol | EXPERIMENTAL | - |
| [18F] Flutemetamol | EXPERIMENTAL | - |
| Flutemetamol (18F) Injection | EXPERIMENTAL | Flutemetamol (18F) Injection |
| 1 flutemetamol | EXPERIMENTAL | - |
| Healthy volunteers | EXPERIMENTAL | 185 MBq \[18F\] Flutemetamol |
| Mild cognitive impairment | EXPERIMENTAL | 185 MBq \[18F\] Flutemetamol |
| Alzheimer's Disease | EXPERIMENTAL | 185 MBq \[18F\] Flutemetamol |
| Name | Type | Description |
|---|---|---|
| [18F]Flutemetamol | DRUG | No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies. |
| [18F] Flutemetamol | DRUG | Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection. |
| Flutemetamol (18F) Injection | DRUG | All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq. |
Inclusion Criteria: * Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq. * The subject was classified as one of the following: 1. End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of ...
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Flutemetamol is an investigational small molecule being studied for use in neurology, specifically for conditions including mild cognitive impairment, Alzheimer's disease, healthy subjects, normal pressure hydrocephalus, and brain fibrillar levels. It is a positron emission tomography (PET) amyloid imaging agent under development by GE HealthCare Technologies Inc. (GEHC).
Flutemetamol is a PET amyloid imaging agent, meaning it is designed to bind to amyloid plaques in the brain for visualization via positron emission tomography. It is being studied to assess its prognostic usefulness in identifying subjects with amnestic mild cognitive impairment who may convert to clinically probable Alzheimer's disease.
Flutemetamol is being developed by GE HealthCare Technologies Inc., traded on the New York Stock Exchange under the ticker GEHC. The company is conducting clinical trials to evaluate the drug's use in PET amyloid imaging of the brain across various patient populations.
Flutemetamol is in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 2 trial, with no active trials currently ongoing. The drug remains investigational and has not been reported as approved by regulatory authorities.
Flutemetamol has completed several clinical trials, including NCT01028053, a Phase 3 study assessing its prognostic usefulness in amnestic mild cognitive impairment conversion to Alzheimer's disease, and NCT01265394, a Phase 3 PET amyloid imaging study in healthy young adults. Additional completed trials include NCT01672827 and NCT02813070.
Yes, Flutemetamol is also known as [18F]Flutemetamol, as referenced in clinical trial NCT01672827, which evaluates an electronic training program for orienting and interpreting [18F]Flutemetamol PET images. This alternative name is used in scientific literature and trial documentation.