LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response
- NCT ID
- NCT07459959
- Registry status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Johns Hopkins University
- Conditions
- Alzheimer s Disease
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Enrollment: 40 participants (Estimated).
What is being studied
- Intervention: Capsules
- Intervention: Dosage Forms
- Intervention: lithium orotate
- Drug: Lithium orotate
- Drug: Matched Placebo (Capsules)
- Intervention: Pharmaceutical Preparations
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- All
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* 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
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)
Study locations
No study locations are listed in the registry data.
Study details
- Start date
- December 1, 2026
- Primary completion date
- June 1, 2029
- Completion date
- August 31, 2029
- First posted
- March 10, 2026
- Collaborators
- National Institutes of Health (NIH)
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07459959
- Registry last updated
- October 7, 2026
- QualifiedStudies registry data refreshed
- October 12, 2026
- QualifiedStudies record fetched
- October 12, 2026
View NCT07459959 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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