Trial Profile

The first Phase II "Lithium in Brain" clinical trial at Massachusetts General Hospital (MGH) - bioequivalence clinical study of AL001 compared to Lithium-carbonate, in healthy human subjects.

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 16 Apr 2026

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At a glance

07 Apr 2026 Results presented in the Alzamend Neuro media release.
26 Mar 2026 According to the Alzamend Neuro media release, the company will enroll a total of 30 patients across the full "Lithium in Brain" program- comprising 5 studies- 1st trial is in healthy subjects, 2nd in BD, while 3rd, 4th, and 5th studies are in patients with MDD, PTSD and Alzheimer's, respectively.
26 Mar 2026 According to the Alzamend Neuro media release, achievement of bioequivalence by AL001 compared to the reference drug (Lithium carbonate) in this study supports a Section 505(b)2 new drug application submission for safety, potentially mitigating non-clinical requirements.

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