AL001 · program

AL001 (lithium–salicylate–L-proline) for Alzheimer's disease

Phase 1/2ActiveAlzamend Neuro, Inc. (ALZN)

Indications for AL001: Bipolar disorder · Phase 1/2 Alzheimer's disease · Phase 1/2

Alzamend Neuro's AL001 lithium ionic cocrystal in Alzheimer's disease — the company's founding indication. The Phase 1/2A multiple-ascending-dose study (NCT05363293, AL001-ALZ02; 65 participants, mild-to-moderate AD patients plus healthy non-elderly and elderly adults) completed in April 2023, establishing safety/tolerability of ascending oral doses. The subsequent healthy-subjects 'Lithium in Brain' PK/MRS crossover study (NCT06921590, attached to the bipolar record as its direct design precursor) completed its clinical phase in November 2025. Alzamend has stated (2026 press releases) that an Alzheimer's patient 'Lithium in Brain' study will follow the recruiting bipolar I study, alongside announced MDD and PTSD studies — but no AD trial is registered as of 2026-08-31, so this program's phase reflects the completed Phase 1/2A. Status 'active' rests on the sponsor's explicit continued-development statements; revisit if no AD study registers.

Data current as of

Development timeline

Phase 1/2May 2022 – Apr 2023
  1. The MAD study reached primary completion (registry actual date; study completion 2023-05-15). Since then the AD program has advanced through platform-level work — the healthy-subjects 'Lithium in Brain' PK/MRS study (clinical phase completed November 2025) and the recruiting bipolar I study — with an AD patient imaging study announced to follow; none registered yet as of 2026-08-31.
  2. Phase 1/2A multiple-ascending-dose study of AL001 (NCT05363293, AL001-ALZ02) started: safety, tolerability and PK of ascending oral doses in mild-to-moderate Alzheimer's patients and healthy non-elderly/elderly adults, 65 participants.

Clinical trials in Alzheimer's disease

NCT05363293AL001-ALZ02Phase 1/2Completedn=65

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

Started May 2022· Primary completion Apr 2023· 📍 2 sites across 2 countries (United States, Canada)

Formulations

FormulationRouteRegimenPharmacokinetics
AL001 oral capsule (three times daily)ionic cocrystal (lithium–salicylate–L-proline)
Oral capsule. The Phase 1/2A multiple-ascending-dose study (NCT05363293) tested ascending doses in mild-to-moderate Alzheimer's patients and healthy non-elderly/elderly adults; the MGH 'Lithium in Brain' crossover studies dose three times daily for 14 days per period head-to-head against immediate-release lithium carbonate.
OralThree times daily—

Mechanism of action (compound-wide)

The active moiety is lithium, whose canonical molecular actions include direct inhibition of glycogen synthase kinase-3 (GSK-3) and of inositol monophosphatase (IMPase). In Alzheimer's disease the rationale leans on lithium's GSK-3β inhibition — GSK-3β is a principal tau kinase, and low-dose lithium has been repeatedly explored as a disease-modifying candidate in AD — combined with AL001's delivery premise: an ionic cocrystal of lithium with salicylate and L-proline engineered to raise brain lithium relative to systemic exposure versus lithium carbonate, potentially enabling chronic dosing in an elderly population without the toxicity and therapeutic-drug-monitoring burden of marketed lithium salts.

TargetActionAffinity
GSK-3βprimaryGSK3BInhibitor—ⓘ
IMPaseIMPA1Inhibitor—ⓘ

← Full AL001 compound page (identity, identifiers, all indications)

Sources

  1. NCT05363293 (AL001-ALZ02) — Phase 1/2 multiple-ascending-dose study of AL001 in mild-to-moderate Alzheimer's patients and healthy adults; COMPLETED, primary completion 2023-04-14 — ClinicalTrials.gov (U.S. National Library of Medicine)
  2. Validating GSK3 as an in vivo target of lithium action (open-access; lithium's direct inhibition of GSK-3 and IMPase) — PubMed Central