LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response

Exclusion Criteria

• •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)