Alzamend Neuro’s AL001 “Lithium in Brain” Study Kicks Off at MGH, Aiming to Redefine Alzheimer’s and Mood Disorder Treatments

May 13, 2025

With Topline Data by Year-End, AL001’s Head-to-Head Battle Against Lithium Carbonate Could Revolutionize the $15B Neuropsychiatric Market

DENVER, Colo., May 13, 2025 (247marketnews.com)- Alzamend Neuro (NASDAQ:ALZN) dropped a bombshell yesterday, announcing the launch of its first Phase II clinical trial for AL001 at Massachusetts General Hospital (MGH), a move that could reshape the $15 billion neuropsychiatric treatment landscape. Dubbed the “Lithium in Brain” study, this trial pits AL001, a novel lithium formulation, against marketed lithium carbonate in healthy subjects, with topline data expected by year-end 2025. By leveraging a cutting-edge head coil from Tesla Dynamic Coils BV, Alzamend aims to prove AL001’s superior brain absorption and reduced systemic side effects, potentially eliminating the need for cumbersome therapeutic drug monitoring (TDM). With mouse studies already showing enhanced brain delivery and lower blood lithium levels, AL001 could revolutionize care for Alzheimer’s disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD).

Stephan Jackman, Alzamend’s CEO, said, “With AL001, we can potentially introduce a next-generation lithium treatment that offers enhanced safety, better brain targeting, and no need for TDM, promising a leap forward from the current, burdensome options. This advancement stands to potentially enhance the lives of over 43 million Americans suffering from Alzheimer’s, BD, MDD and PTSD by providing a safer, more effective and user-friendly therapeutic option, potentially reshaping current treatment paradigms and improving patient quality of life substantially.”

AL001: A Lithium Revolution in the Making

Alzamend’s Phase II trial, initiated May 12, 2025, at MGH, is a head-to-head showdown comparing AL001’s pharmacokinetics in blood and brain structures to a marketed lithium carbonate product in healthy subjects. This baseline study will guide future trials in Alzheimer’s, BD, MDD, and PTSD patients, aiming to demonstrate AL001’s targeted brain efficacy with minimal systemic exposure. Unlike conventional lithium salts, which require frequent TDM due to a narrow therapeutic window and risks of kidney and thyroid toxicity, AL001’s novel formulation, backed by mouse studies showing superior brain absorption and lower blood levels, promises safer, more efficient delivery. By potentially eliminating TDM, AL001 could transform lithium’s role as a first-line therapy for BD’s manic episodes and maintenance, currently underutilized due to dosing complexities, per a 2023 American Journal of Psychiatry report.

Strategic Impact and Market Opportunity

The trial’s collaboration with MGH, a global leader in medical research, and the use of Tesla Dynamic Coils’ novel head coil for precise brain imaging, underscore ALZN’s cutting-edge approach. Lithium’s efficacy in BD, MDD, and emerging Alzheimer’s applications is well-documented, but its side effects and TDM requirements limit adoption. AL001’s potential to maintain therapeutic brain levels with fewer daily doses could capture a significant share of the $15 billion neuropsychiatric drug market, projected to grow at a 5% CAGR through 2030 (MarketsandMarkets). Mouse studies, showing reduced systemic lithium levels while enhancing brain delivery, suggest AL001 could minimize risks like nephrotoxicity, a major barrier to lithium use, per a 2024 Journal of Clinical Psychiatry study.

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