Clinical Trial

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 Healthy Adult Subjects

Completed Phase 1
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are: How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate? Participants will be asked to: * Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days * Stay overnight at MGH's research unit for two separate 2-week periods * Participate in two separate 24 hour periods of multiple MRIs and blood draws
Protocol Amendment History 3 changes
critical Trial completed 2026-07-30
critical Primary endpoint(s) modified 2026-07-30
notable Enrollment increased: 6 -> 15 participants 2026-07-30
Trial Details
NCT Number NCT06921590
Lead Sponsor Alzamend Neuro, Inc.
Collaborators: Massachusetts General Hospital
Conditions Pharmacokinetics, Neurology
Enrollment 15 participants
Start Date 2025-05-09
Primary Completion 2025-12-15 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-29