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A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability 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

Trial Profile

A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability 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

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 01 Oct 2025

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At a glance

  • Drugs Lithium cocrystal Alzamend Neuro (Primary) ; Lithium
  • Indications Alzheimer's disease; Bipolar disorders; Major depressive disorder; Post-traumatic stress disorders
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms Lithium in Brain
  • Sponsors Alzamend Neuro

Most Recent Events

  • 28 Jul 2025 According to an Alzamend Neuro media release, the company announced it will have a poster presentation at the Military Health System Research Symposium, being held from August 4-7, 2025, in Orlando, Florida.
  • 23 Jul 2025 According to an Alzamend Neuro media release, In May 2025, company dosed the first patient for the healthy human patients for the AL001 "Lithium in Brain" Studies at Massachusetts General Hospital.
  • 29 Jun 2025 Status changed from recruiting to active, no longer recruiting.

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