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Study identifier: NCT07540338 Synced from ClinicalTrials.gov · July 28, 2026
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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

Condition: Bipolar I Disorder  ·  Sponsor: Alzamend Neuro, Inc.

PhasePhase 1/Phase 2
Planned participants20
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are: * How safe 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.

This description comes directly from the study's public registry record.

Talk to the study team

Eve del Rio, MD, PhD  ·  (908) 672-6388  ·  eve@riopharma.com

Always discuss trial participation with your own doctor first.

Locations (1)

Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07540338