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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 7, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07459959). This is a study registration, not published results. Lead sponsor: Johns Hopkins University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Alzheimer s Disease. Interventions: DRUG: Lithium orotate; DRUG: Matched Placebo (Capsules). Primary outcome measures: Feasibility (Recruitment, Retention) , Baseline up to Week 9; Feasibility (Visit Completion) , Baseline up to Week 9; Feasibility (Adherence) , Baseline up to Week 9; Safety (Frequency of Adverse Events) , Baseline up to Week 11 (includes Safety Follow-up); Safety (Adverse Events Relatedness) , Baseline through Week 11 (includes Safety Follow-up); Safety (Adverse Events Severity) , Baseline through Week 11 (includes Safety Follow-up); Safety (Renal function) , Baseline through Week 11 (includes Safety Follow-up); Safety (Thyroid functioning) , Baseline through Week 11 (includes Safety Follow-up); Tolerability (Dose Modifications) , Baseline up to Week 9; Tolerability (Discontinuations) , Baseline to Week 9. Brief summary: The goal of this clinical trial is to assess feasibility, safety, tolerability, and central nervous system target engagement of oral lithium orotate in adults with biomarker-confirmed early Alzheimer's disease. The main questions it aims to answer are: * Can participants be recruited, retained, and remain adherent (target ≥80%) over 9 weeks of treatment, and what is the frequency and severity of adverse events? * Does lithium orotate increase cerebrospinal fluid (CSF) lithium concentration from baseline to 9 weeks compared with placebo? Researchers will compare daily lithium orotate to matched placebo to see if lithium orotate demonstrates acceptable feasibility, safety, and tolerability and engages the central nervous system target (CSF lithium). Participants will: * Be randomized in a double-blind manner to receive lithium orotate or placebo for 9 weeks, with titration from week 1: 240 mg/day (10mg elemental lithium) to week 2: 480 mg/day (20mg elemental lithium) and week 3: 720 mg/day (30mg elemental lithium) if tolerated; dose reductions are permitted for side effects. * Attend study visits for safety monitoring, adherence support (caregiver pill logs/diaries), and review of concomitant medications and adverse events. * Provide blood samples and undergo lumbar punctures at baseline and post-treatment to measure CSF and serum lithium and Alzheimer's-related biomarkers; complete brief cognitive testing and neuropsychiatric symptom assessments.