Actively Recruiting
Study Comparing the Safety and Brain Effects of AL001 Versus Lithium Carbonate in Adults With Bipolar I Disorder
Led by Alzamend Neuro, Inc. · Updated on 2026-07-28
20
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a new crystallized form of lithium called AL001 compared to the commonly used lithium carbonate in adults diagnosed with Bipolar I Disorder. The study aims to understand how AL001 is processed in the brain and body and to assess its safety profile. This research builds on past findings suggesting AL001 may have a stronger effect, potentially allowing for lower doses and fewer side effects, which could provide new treatment options for psychiatric and neurological conditions. Participants in this study will undergo two separate treatment periods, each lasting 14 days, during which they will take AL001 and lithium carbonate in a randomized sequence with a washout period in between. Each participant will stay overnight at Massachusetts General Hospital for these two separate two-week periods. During each stay, participants will take the assigned study drug three times daily and undergo frequent blood draws and brain MRI scans, especially during two 24-hour monitoring periods, to evaluate how the drug reaches and is processed in the brain and plasma. Throughout the study, participants will be closely monitored with multiple MRIs, blood tests, physical exams, and mental health assessments to ensure safety and collect pharmacokinetic data. The study will track how lithium from AL001 and lithium carbonate moves through the brain and body over 24-hour periods at steady state. Safety and tolerability will also be evaluated from enrollment through follow-up up to Day 42. Participants must adhere to study procedures and restrictions, including overnight stays and contraceptive requirements, with total participation lasting several weeks including follow-up assessments.
CONDITIONS
Brief Title
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
Research Team
E
Eve del Rio, MD, PhD
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