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Alzamend Neuro Initiates Phase II Clinical Trial of AL001 "Lithium in Brain" Study in Patients with Bipolar Disorder in Collaboration with Massachusetts General Hospital
Head-to-head studies of AL001 versus marketed lithium carbonate will compare lithium blood and brain/brain-structure pharmacokinetics in bipolar disorder type
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"Head-to-head studies of AL001 versus marketed lithium carbonate will compare lithium blood and brain/brain-structure pharmacokinetics in bipolar disorder type 1 patientsTopline data expected in third quarter of 2026Topline data from the clinically completed \"lithium in brain\" imaging study in healthy subjects expected by the end of March 2026ATLANTA, March 16, 2026 /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (\"Alzamend\"), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease (\"Alzheimer's\"), bipolar disorder (\"BD\"), major depressive disorder (\"MDD\") and post-traumatic stress disorder (\"PTSD\"), today announced the initiation of its Phase II clinical trial evaluating AL001 in patients diagnosed with BD type 1. The trial is being conducted at Massachusetts General Hospital (\"MGH\") and represents a significant step toward advancement of AL001 as a potentially safer and more effective lithium-based therapy.\n \n \n \n \n \n \n \nThis Phase II study builds upon Alzamend's prior \"Lithium in Brain\" clinical trial in healthy subjects, for which the clinical portion was completed in November 2025. Topline data from that study are expected by the end of March 2026. Following completion in healthy volunteers, Alzamend and MGH are now expanding the program to subjects with BD type I, with plans to also initiate further trials in the near future in MDD, Alzheimer's and PTSD.The study will utilize a crossover design intended for multiple six-subject cohorts. Following screening, participants are randomized into one of two treatment sequences: AB (AL001 followed by lithium carbonate) or BA (lithium carbonate followed by AL001). Each treatment period consists of 14 days of 3-times daily (\"TID\") dosing. A washout period of 14 days is planned between treatment periods.During days 14 and 15 of each treatment period, participants undergo intensive 24-hour lithium pharmacokinetic blood sampling in conjunction with advanced magnetic resonance imaging (\"MRI\") and magnetic resonance spectroscopy (\"MRS\") neuroimaging. The MRI and MRS neuroimaging methods were developed by the lab of Dr. Ovidiu Andronesi, the study's principal investigator, Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Cente...