Alzamend Neuro Advances Lithium Imaging Research

ATLANTA, August 18, 2026

7T MRI Offers New View of Lithium in the Brain

The presentation, titled “Pharmacokinetics Imaging of Lithium at 7T – Results from a Phase 1/2A Clinical Trial with a Novel Organic Lithium Salt,” was selected through competitive review and is scheduled for the Proffered Papers oral session on September 29. The data will be presented by Dr. Ovidiu C. Andronesi, principal investigator of Alzamend’s Phase 1/2A trial and a specialist in multinuclear MRI. The study uses advanced 7T lithium imaging to examine lithium concentrations in the brain and individual brain structures alongside blood pharmacokinetic measurements. According to Alzamend, the imaging approach provides an opportunity to understand lithium distribution beyond conventional blood-level measurements. The Phase 1/2A study used a randomized crossover design involving multiple six-subject cohorts. Participants received either AL001 followed by lithium carbonate or lithium carbonate followed by AL001, with each treatment period lasting 14 days and separated by a 14-day washout period. On Days 14 and 15, participants underwent 24-hour blood sampling together with MRI and MRS neuroimaging.

AL001 Targets Improved Lithium Brain Delivery

AL001 is an investigational ionic cocrystal formulation of lithium combined with L-proline and salicylate. Alzamend is developing the candidate with the goal of delivering therapeutic lithium to the brain while potentially reducing systemic exposure associated with conventional lithium formulations. Lithium has been used for decades in the treatment of bipolar disorder, but its clinical use can be complicated by a narrow therapeutic window and the requirement for regular monitoring because of potential systemic toxicities. Alzamend is investigating whether AL001 can provide a differentiated pharmacokinetic and tolerability profile while maintaining appropriate lithium exposure. The company reported that results from the Phase 1/2A study confirmed that AL001 matches blood levels of standard lithium carbonate, which Alzamend says addresses regulatory requirements for a new formulation. The imaging component is intended to provide additional information about lithium concentrations within the brain and potentially support understanding of AL001’s proposed dose-sparing characteristics. The study incorporated a specialized engineered head coil developed by Tesla Dynamic Coils BV to enable high-resolution whole-brain lithium imaging. The approach was designed to allow researchers to simultaneously evaluate lithium concentrations in blood and brain tissue while examining brain chemistry, metabolism and biomarker effects.

Potential Applications Across Neuropsychiatric Diseases

Alzamend is developing AL001 for several neurological and psychiatric conditions, including Alzheimer’s disease, bipolar disorder type 1, major depressive disorder and post-traumatic stress disorder. The company believes that improved understanding of lithium pharmacokinetics in the brain could help guide future development of the candidate across these indications. The upcoming ISMRM presentation represents an opportunity to share the Phase 1/2A imaging findings with researchers specializing in X-nuclei magnetic resonance imaging, an emerging field that extends MRI beyond conventional proton imaging. While the data may provide additional insight into AL001’s distribution, further clinical research will be required to establish its safety, efficacy and therapeutic benefits in patients with disease. Alzamend’s pipeline also includes ALZN002, an investigational cell-based therapeutic vaccine being developed for Alzheimer’s disease. The company continues to evaluate its novel therapeutic approaches as it seeks to develop potentially safer and more targeted treatments for neurological and psychiatric disorders.

Source: Alzamend Neuro press relese