Alzamend Neuro has announced the determination of the maximum tolerated dosage (MTD) for AL001, its investigational lithium-based therapy aimed at treating Alzheimer's disease and other related dementias. This development marks a significant step forward as the company prepares to advance AL001 into further clinical trials, potentially offering a safer and more manageable alternative to existing lithium treatments. The identified dose, equivalent to 240 mg of lithium carbonate taken three times daily, is expected to minimize the need for intensive therapeutic drug monitoring (TDM), a common challenge associated with traditional lithium formulations.
Overcoming Limitations of Traditional Lithium Therapy
Traditional lithium therapy, while potentially beneficial in managing Alzheimer's disease by reducing the accumulation of toxic amyloid plaques and tau tangles and promoting nerve cell survival, is often complicated by its narrow therapeutic window. This necessitates frequent blood tests to ensure drug concentrations remain within a safe and effective range. Alzamend's AL001 is designed to mitigate these challenges, offering a more tolerable and convenient treatment option.
Stephan Jackman, CEO of Alzamend, emphasized the importance of this milestone, stating that the data not only underscores AL001's safety and tolerability but also suggests its potential to transform patient care by reducing the need for intensive TDM. This could significantly enhance both the effectiveness and safety of lithium therapy in clinical practice.
Phase 1/2 Trial Results: Safety and Tolerability
The MTD was identified through a Phase 1/2 clinical trial (NCT05363293) that assessed the safety, tolerability, and pharmacological properties of AL001 in both healthy volunteers and individuals with Alzheimer's disease. The trial results indicated that AL001 was well-tolerated across all dose levels, with a "benign" safety profile. Furthermore, pharmacological data revealed no significant differences in drug response between participants with and without Alzheimer's, or between elderly and non-elderly healthy volunteers.
Future Clinical Trials and Collaborations
Building on these promising findings, Alzamend Neuro is partnering with Massachusetts General Hospital to conduct five Phase 2 clinical trials, collectively referred to as the "Lithium in Brain" studies. These trials will evaluate the efficacy of AL001 in patients with mild to moderate Alzheimer's disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). This comprehensive clinical program aims to further elucidate the therapeutic potential of AL001 across a range of neurological and psychiatric conditions.
"We look forward to further evaluating AL001 in five ‘Lithium in Brain’ Phase II clinical trials in healthy subjects and patients diagnosed with mild to moderate Alzheimer’s, BD, MDD and PTSD, in partnership with Massachusetts General Hospital," Jackman added. These trials will be crucial in determining the clinical benefits and optimal use of AL001 in diverse patient populations.
