Data Supports Efficacy of New Flutemetamol Imaging Agent for Detection of Amyloid Plaque

June 15, 2012 — Data presented at the Society for Nuclear Medicine (SNM) Annual Meeting shows that uptake of the investigational imaging agent [¹⁸F] flutemetamol correlates with a beta amyloid in vivo biopsy and can be quantified using a positron emission tomography (PET)-only registration method. Data from other studies show that flutemetamol (F18) uptake is inversely related to measures of cognitive function in non-demented older adults. Additionally, the flutemetamol (F18) dosimetry profile is comparable to that of most PET diagnostic radiopharmaceuticals and the biodistribution attributes in Japanese and Caucasian subjects is comparable. Flutemetamol (F18) is a PET imaging agent in development for the detection of beta amyloid, which could add value to current diagnostic tools used by physicians to evaluate neurodegenerative conditions like Alzheimer’s disease (AD). 

The accumulation of beta amyloid in the brain is believed to play a role in the degeneration of neurons in AD and is one of several pathological characteristics implicated in its development. Currently, AD is confirmed by histopathological identification of core features, including beta amyloid plaques, in postmortem brain samples. Targeted amyloid imaging agents are being studied to determine their ability to help physicians detect amyloid deposition in living humans.

Data from studies featured at the meeting in Miami show that:

• In a comparison of automated quantification methods using 72 images from the flutemetamol (F18) phase 2 study, a PET-only method produced very similar results to an MR-based method using FreeSurfer. Furthermore, when applied to AIBL data, the automated PET-only method produced results that were very similar to those obtained when a trained expert manually placed regions on co-registered MRI. The results show that the automated quantification method produced accurate and robust results without further use of MRI.
• Two phase 1 studies of flutemetamol (F18) in healthy Japanese volunteers and in subjects with probable AD showed that radiation dosimetry profiles in healthy volunteers were both comparable to those of most PET diagnostic radiopharmaceuticals and that biodistribution attributes were similar in Japanese and Caucasian populations of health volunteers and patients with probable AD.
• In pooled analysis from four studies of 49 patients receiving flutemetamol (F18) before or after brain biopsy during shunt placement or intracranial pressure measurement, flutemetamol (F18) detected visual reads correlated with biopsy with an overall majority read sensitivity of 93 percent and specificity of 100 percent.
• In a separate study of 11 community-dwelling non-demented older adults with subjective memory complaints, which compared the relationship between flutemetamol (F18) uptake and measures of cognitive performance (delayed memory index from RBANS), flutemetamol (F18) uptake showed a significant negative correlation when the delayed memory index was adjusted for pre-morbid IQ.

Flutemetamol (F18) is one part of a broad portfolio of diagnostic solutions that GE Healthcare is currently developing in the Alzheimer’s field. The company is taking a comprehensive approach to understanding AD through its ongoing research to uncover the causes, risks, and physical effects of the disease. GE Healthcare’s global commitment to advance clinical knowledge and provide a variety of technologies to aid in the fight against this epidemic may assist physicians in the acceleration of diagnosis and improvement of treatment decisions in all stages of the disease.

The company already offers a broad portfolio of imaging resources, which support accurate visualization of the signs of neurodegenerative diseases via state-of-the-art scanners - including MRI, PET, and CT - that deliver clear visualization of the brain. More specifically, our portfolio today includes cyclotrons and chemistry systems to manufacture PET imaging agents, PET and MR scanners to scan patients, and image analysis software to interpret the results. 

GE Healthcare has been a key contributor to the Alzheimer’s Disease Neuroimaging Initiative (ADNI) since its inception. The company also plays a primary role in PredictAD, an EU-funded research project to develop solutions to enable earlier diagnosis of AD, and in the Coalition Against Major Diseases (CAMD).