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Alzamend Neuro Partners with Massachusetts General Hospital for a Phase II Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, involving Patients with Bipolar Disorder
Harvard University Associate Professor, Dr. Ovidiu Andronesi MD, PhD, will be the principal investigator of the study Head-to-head study of AL001 versus a
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nHarvard University Associate Professor, Dr. Ovidiu Andronesi MD, PhD, will be the principal investigator of the study\n\n\n\nHead-to-head study of AL001 versus a marketed lithium carbonate product will be conducted; the goal is to compare lithium in human brain and brain structures to identify a potentially ideal dose of AL001 that is safe and effective as current products\n\n\n\n ATLANTA--(BUSINESS WIRE)--\nAlzamend 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 that it is partnering with Massachusetts General Hospital as its contract research organization (“CRO”) to conduct first of its kind Phase II clinical study of AL001 for treatment of patients with BD. Massachusetts General Hospital is the original and largest clinical education and research facility of Harvard Medical School/Harvard University and houses the world's largest hospital-based research program.\n\n\nAlzamend and Mass General have contracted with Dr. Ovidiu Andronesi, MD, PhD, to be the principal investigator on the study. Dr. Andronesi is an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School.\n\n\nLithium was the first mood stabilizer approved by the U.S. Food and Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”) for BD. Moreover, lithium has been marketed for more than 35 years and human toxicology regarding its use has been well characterized, potentially mitigating the regulatory burden for safety data. The objective of this novel trial is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among BD patients. By examining the lithium content in the brains and brain structures of patients during treatments, Alzamend aims to predict the minimum dose necessary to achieve the equivalent effectiveness and safety of AL001 in contrast to established lithium salts. Alzamend is optimistic that this study ...