Alzamend Neuro, Inc. (NASDAQ: ALZN) initiated a Phase II clinical trial of AL001 in patients with bipolar disorder type 1, according to a company statement. The study is being conducted at Massachusetts General Hospital and will compare AL001 to lithium carbonate.

The trial uses a crossover design with multiple six-subject cohorts. Participants receive either AL001 followed by lithium carbonate, or lithium carbonate followed by AL001, with each treatment period lasting 14 days of three-times-daily dosing. A 14-day washout period separates the treatment phases.

The study incorporates magnetic resonance imaging and magnetic resonance spectroscopy to measure lithium concentrations in blood and brain tissue. Dr. Ovidiu Andronesi, Associate Professor of Radiology at Harvard University and Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging, serves as principal investigator.

Topline data from the bipolar disorder trial are expected in the third quarter of 2026. Results from a completed "lithium in brain" study in healthy subjects are expected by the end of March 2026.

AL001 is designed as a lithium delivery system that aims to provide brain-targeted lithium distribution while reducing systemic exposure. In previous non-clinical studies, AL001 demonstrated higher brain tissue lithium concentrations at lower doses compared to lithium carbonate.

The company's Phase IIA multiple-ascending dose study established a maximum tolerated dose of AL001 equivalent to 240 mg of lithium carbonate three times daily. This dose was selected to maintain plasma lithium levels below those associated with potential toxicity.

"Our goal with AL001 is to optimize brain lithium delivery while reducing systemic exposure and potentially eliminating the need for burdensome therapeutic drug monitoring," said Stephan Jackman, Chief Executive Officer of Alzamend.

Alzamend plans to initiate additional trials for AL001 in major depressive disorder, Alzheimer's disease and post-traumatic stress disorder.