Core Viewpoint - Alzamend Neuro, Inc. has initiated its first Phase II clinical study of AL001, a novel lithium-delivery system aimed at treating Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, with the first patient dosed in the trial [1][4]. Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [6]. - The company's pipeline includes two therapeutic candidates: AL001, which utilizes patented ionic cocrystal technology for lithium delivery, and ALZN002, a cell-based therapeutic vaccine targeting Alzheimer's [6]. Product Details - AL001 is designed to enhance lithium delivery to the brain while minimizing systemic side effects and the need for therapeutic drug monitoring (TDM) [3][5]. - Previous studies indicated that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, potentially leading to safer treatment options [2][5]. - The formulation aims to reduce the risks associated with traditional lithium therapies, such as kidney and thyroid side effects, by favorably distributing lithium in the brain [3][5]. Clinical Study Insights - The Phase II study will assess AL001's effectiveness in healthy subjects, serving as a baseline for future studies in patients with Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [2][4]. - Topline data from the study is expected to be announced before the end of 2025 [4][9]. - Head-to-head studies comparing AL001 with marketed lithium carbonate products will be conducted to evaluate pharmacokinetics in healthy subjects [9].