NCT07459959Not yet recruitingPhase 1/2
LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- Johns Hopkins University
- Diseases
- Alzheimer disease
- NCT number
- NCT07459959
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Dec 2026 to the primary completion date, 1 Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- New or unstable neurological disorder or unstable psychiatric illness that could affect safety or study results
Other
- 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)
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.