Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [18F] Flutemetamol, Flutemetamol (18F) Injection, 18F, AH110690
Flutemetamol · 6 trials · 6 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.
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 | - |
| 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, 111 to 370 MBq (3 to 10 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. |
| AH110690 (18F) Injection | DRUG | All subjects will receive an I.V. dose of \[18F\]AH110690 (less than 10 mg of total AH110690). The target activity of a single administration of \[18F\]AH110690 will be 185 MBq (equivalent to a dose of approximately 6 mSv). |
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 a PET imaging agent used to evaluate beta-amyloid in the brain. It is studied in Alzheimer's disease, mild cognitive impairment, brain fibrillar amyloid levels, and normal pressure hydrocephalus. It is a small molecule radiopharmaceutical developed by GE HealthCare Technologies Inc. for neurology applications.
Flutemetamol is developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company holds the asset as a PET amyloid imaging agent in its neurology portfolio.
Flutemetamol is in Phase 3 development. Its clinical program includes completed Phase 3 studies along with a completed Phase 2 study. It is an investigational imaging agent and remains in clinical development.
Flutemetamol has been studied in completed trials including NCT01672827, which evaluated an electronic training program for interpreting [18F]Flutemetamol PET images, and NCT01165554, which compared PET imaging of brain amyloid with post-mortem levels. Other completed studies include NCT02813070 and NCT01053312.
Yes. Flutemetamol is also known as [18F]Flutemetamol, Flutemetamol (18F) Injection, and [18F]Flutemetamol. These names refer to the same PET amyloid imaging agent developed by GE HealthCare Technologies Inc.