Berlin, Germany, 28 September 2022. Life Molecular Imaging (LMI) is extremely excited about the positive news shared by Eisai US and Biogen around the positive topline results from Eisai’s large global Phase 3 Clarity AD clinical trial of Lecanemab, an investigational anti-amyloid beta (Aβ) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD with confirmed presence of amyloid pathology in the brain.
The presence of neuritic Aβ plaques, as measured with amyloid PET, was a key inclusion criterion into these studies and allowed appropriate patient selection. Life Molecular Imaging is very humbled to have contributed to the positive study outcome by supplying its Amyloid PET Tracer Neuraceq® (florbetaben F18). The majority of the PET scans were conducted with Neuraceq® in this study in both the US and Europe. LMI is delighted to see that the removal of aggregated Aβ in the brain of these patients is associated with a slowing of clinical decline.
Amyloid PET has shown itself from this and other studies to be an accurate quantitative measure of amyloid plaque removal by active anti-amyloid therapies, such as Lecanemab. The Clarity AD results further support the amyloid hypothesis, in which the abnormal accumulation of Aβ in the brain is one of the main causes of AD. Early detection and accurate diagnosis of AD are key to fight the disease.
A great day for us at LMI but even more for patients suffering from this debilitating disease and their families and caregivers.
Learn more at: CLARITY AD press release
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.
A negative Neuraceq® scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations.
Limitations of Us
A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions and (ii) monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Neuraceq® can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. Neuraceq® is an adjunct to other diagnostic evaluations. Neuraceq® images should be interpreted independent of a patient’s clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positives) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.
Administration of Neuraceq®, like other radiopharmaceuticals, contributes to a patient´s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq® administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centred, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health, and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance’s distributor of radiopharmaceuticals to diagnose many types of diseases. Visit https://www.lifehealthcare.co.za/