UNIVERSITY OF NEVADA, LAS VEGAS

The FDA granted icometrix clearance for icobrain aria, the first AI software to detect, measure, and grade amyloid-related imaging abnormalities (ARIA), a side effect of amyloid-targeting therapies for Alzheimer’s disease. icobrain aria significantly improves ARIA assessment accuracy, enhancing patient safety and facilitating the wider use of these therapies.

FDA approves icobrain aria, the first AI software to detect, diagnose, and monitor Amyloid-Related Imaging Abnormalities (ARIA) in Alzheimer’s patients, enhancing safety of amyloid-targeting therapies.

John Sims presented at CTAD that starting donanemab at low doses and titrating up reduced ARIA-E by 40%, especially for APOE homozygotes. Gil Rabinovici's new donanemab AUR emphasize stricter MRI criteria for safety. Lilly plans to submit data to update the label.

Personalized neuromodulation (rTMS-EEG) targeting the Default Mode Network slowed Alzheimer’s progression in cognition, function, and behavior, with no serious side-effects, according to a 12-month Phase 2 study.

Longeveron's ELPIS I study showed 100% 5-year survival with no heart transplants for HLHS patients treated with Lomecel-B™, compared to 83% survival in the SVR trial. ELPIS I met safety endpoints, and ELPIS II Phase 2b trial is ongoing to further evaluate Lomecel-B™.

Patients treated with Lomecel-B™ in ELPIS I showed 100% 5-year survival post-Glenn surgery, with none requiring heart transplant, compared to 83% survival in the Single Ventricle Reconstruction Trial. ELPIS I met its safety primary endpoint with 100% survival and transplant-free status. ELPIS II Phase 2b trial is ongoing, evaluating Lomecel-B™ as an adjunct therapy for HLHS.

ADDF leads roundtable on combination therapy for Alzheimer’s at 2024 CTAD conference, highlighting the need for precision medicine and novel therapeutic targets beyond amyloid and tau.

FDA approves KarXT, a new schizophrenia treatment by Bristol Myers Squibb, offering improved symptoms and fewer side effects. KarXT, a combination of Xanomeline and trospium, targets muscarinic receptors and reduces digestive issues. The drug is expected to be cost-effective if priced between $16,000 and $20,000 per year, with 75% of patients seeing symptom improvement by 30% or more after one year.

FDA approves Cobenfy, first new schizophrenia drug in over 30 years, combining xanomeline and trospium chloride to manage symptoms via a different mechanism targeting acetylcholine, potentially reducing common side effects like weight gain and drowsiness.