NCT07459959 · Phase 1 · NOT YET RECRUITING
LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response
This trial is testing whether low-dose lithium orotate, a supplement form of lithium, can safely reach the brain in people who already have early, biomarker-confirmed Alzheimer's disease. Researchers want to know if the drug is tolerable and actually shows up in spinal fluid — not yet whether it helps memory. It is a Phase 1 trial, meaning the focus is on safety and basic proof-of-concept, not effectiveness. Nine weeks, placebo-controlled, with two spinal taps required.
You may qualify if
- Diagnosis of Alzheimer's disease confirmed by biomarkers (imaging or biofluid evidence of amyloid-beta and tau pathology)
- Mild stage of Alzheimer's disease: Clinical Dementia Rating (CDR) ≤ 1 or Quick Dementia Rating System (QDRS) ≤ 8
- Medically stable and able to attend study visits and complete study procedures
- On stable doses of any psychotropic medications for at least 4 weeks before the baseline visit
- Not currently receiving anti-amyloid monoclonal antibody therapy
You're excluded if
- New or unstable neurological disorder or unstable psychiatric illness that could affect safety or study results
- Clinically significant kidney or thyroid problems that pose safety concerns, or abnormal safety labs judged to be related to study drug and requiring discontinuation
- Use of thiazide diuretics during the dosing period (unless stopped at least 4 weeks before baseline)
- Chronic daily use of non-aspirin NSAIDs (including COX-2 inhibitors); short courses require study team approval and may require temporary study drug hold and safety labs before resuming
- Starting excluded therapies during the active treatment period (e.g., anti-amyloid monoclonal antibody treatment)
- Noncompliance with essential study procedures that would prevent collection of primary safety or feasibility endpoints (e.g., repeated missed visits or refusal of critical labs)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-08