Alzamend Neuro Inc (NASDAQ: ALZN) has posted positive topline data from its Phase 1 trial for AL001 as an oral treatment for dementia-related to Alzheimer's disease.
The trial was designed to determine the pharmacokinetics, safety, and tolerability of AL001 and target doses for a planned Phase 2 study in Alzheimer's patients.
The participants received a single dose of AL001 containing lithium equivalent to 150 mg lithium carbonate.
Dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption indicate that AL001 is bioequivalent to the marketed 300 mg lithium carbonate product.
The shapes of the lithium plasma concentration versus time curves are similar.
AL001 salicylate plasma concentrations were well-tolerated and consistently within safe limits.
AL001 is a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, L-proline, and salicylate.
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