FDA Approves AIRAscore, Pimavanserin Packing Label Updated, Blarcamesine Data Released

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

According to an announcement, the FDA has granted 510(k) clearance to AIRAmed for AIRAscore, a deep learning and artificial intelligence (AI)-incorporated medical image management and processing tool designed to detect Alzheimer disease (AD) and other related dementias at the earliest point. AIRAscore, which has been commercially available in Europe for 4 years, will be available for purchase in the US in the first quarter of 2024. With AIRAscore, clinicians are able to objectively assess MRI brain scans of patients in a quick manner and compare them with a large reference population, corrected for head size, age, and sex. The technology provides absolute values of volumes of tissues, including information on different lobes and limbic structures. Through this, clinicians can identify brain volumes that are not age appropriate, further aiding in the differentiation of other dementia forms and movement disorders.

According to a new announcement, the FDA has updated the packaging label for pimavanserin an approved therapy for Parkinson disease psychosis, to clarify that the medication may be used for patients with PDP with or without dementia. Pimavanserin, originally approved in a tablet form, became the first medication marketed for the treatment of hallucinations and delusions association with psychosis in patients with PD in 2016. With the new updated label, the agency restated in the Clinical Studies section that the phase 3 study that supported its approval included patients with PDP with or without dementia. Although no risk information was changed, the therapy’s boxed warning language was further clarified to include patients with PDP who also have dementia.

Newly announced findings from a follow-up analysis to the phase 2b/3 study assessing blarcamesine, an investigational therapy, demonstrated a significant reduction in pathological amyloid-ß levels in plasma, as well as a significant slowing in the rate of pathological brain atrophy on MRI scans in treated patients with early Alzheimer disease. According to Anavex, blarcamesine is one of the first therapies to demonstrate efficacy on biomarkers of neurodegeneration and may slow cognitive decline among patients with AD. In the study, blarcamesine-treated patients showed significant increases in validated biomarkers of amyloid-ß pathology, plasma Aβ42/40 ratio (P = .048), further demonstrating the agent’s strong antiamyloid effect. Additionally, MRI findings showed significant reduction in brain volume loss, including whole brain (P = .0005), when blarcamesine was compared with placebo.

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