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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