Alzamend Neuro, Inc.
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 study is researching the effects of a new type of crystallized lithium, AL001, on it's ability to reach the brain and have an effect in subjects with bipolar I disorder diagnosis. The investigators will be comparing this to a commonly used type of lithium, lithium carbonate. Investigators want to see if the AL001 can have the same or better effect when compared to lithium carbonate. Past research has shown a greater effect within the body with AL001 when compared to commonly used lithium. This past research suggests that AL001 may be more effective, potentially allowing for lower doses a…
Inclusion Criteria: 1. Subjects with a primary psychiatric diagnosis of Bipolar I Disorder (BD1) between the age of ≥ 18 and ≤65 years who are in reasonably good physical health, as determined by the DSM-5-TR BD1 diagnostic criteria and the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laboratory tests. 2. Assessment of subject's mental health status will be conducted to avoid enrolling subjects who are on the verge of a manic or depressive episode. Affective stability, defined by a Youn…
Crystallized lithium
Lithium carbonate
Arctuva estimate
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