Alzamend Neuro partners with Massachusetts General Hospital, a renowned Harvard Medical School research facility, to conduct a groundbreaking Phase II clinical study of AL001 for treating Major Depressive Disorder (MDD).
Lithium, the first FDA-approved mood stabilizer, has been used off-label for MDD augmentation. Alzamend aims to demonstrate the potential of AL001 as an enhanced lithium formulation.
The study will compare the lithium levels in the brains of MDD patients receiving AL001 to those receiving a standard lithium salt. By studying lithium distribution within brain structures, Alzamend hopes to determine an optimal dose for AL001 that matches the effectiveness and safety of traditional lithium salts.
AL001, if successful, may potentially reduce the need for therapeutic drug monitoring commonly associated with FDA-approved lithium salts. The study aims to pave the way for AL001’s approval through the Section 505(b)(2) pathway designed for innovative formulations of established drugs.
Alzamend’s previous Phase IIA trial established a maximum tolerated dose for AL001, reducing the likelihood of requiring regular blood monitoring to ensure therapeutic levels. The ongoing collaboration with Massachusetts General Hospital and the expertise of Dr. Ovidiu Andronesi as the principal investigator reinforce Alzamend’s commitment to developing a novel treatment approach for MDD.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
