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LiO-AD

Not yet recruitingPhase 1 / PHASE2

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

Lead sponsor

Johns Hopkins University

Asset

Lithium orotate

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required•Tau biomarker required

Primary endpoints

•Feasibility•Feasibility (Visit Completion)•Feasibility (Adherence)

Identifiers

Registered as

Org study IDIRB00540477

NCT IDNCT07459959

Timeline

Milestones

Study first posted2026-03-10actual

Last update posted2026-06-08actual

Study start2026-10-01estimated

Primary completion2029-06-01estimated

Study completion2029-08-31estimated

Assets

Drug assets

Lithium orotate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

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)

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes

Global cognition

Behavior / neuropsychiatric

Neurodegeneration biomarkers

Fluid / digital biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

Delayed Recall

Time frame:Baseline up to Week 9

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric Symptoms (NPI-Q)

Time frame:Baseline up to Week 9

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Change in neurofilament light chain (NfL)

Time frame:Baseline up to Week 9

Neurofilament light (NfL)

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Central Nervous System Target Engagement (CSF Lithium Change)

Time frame:Baseline up to Week 9

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Safety (Frequency of Adverse Events)

Time frame:Baseline up to Week 11 (includes Safety Follow-up)

event count, event

Primary/protocol endpoint

Safety (Adverse Events Relatedness)

Time frame:Baseline through Week 11 (includes Safety Follow-up)

event count, event

Primary/protocol endpoint

Safety (Adverse Events Severity)

Time frame:Baseline through Week 11 (includes Safety Follow-up)

event count, event

Primary/protocol endpoint

Safety (Renal function)

Time frame:Baseline through Week 11 (includes Safety Follow-up)

descriptive

Primary/protocol endpoint

Safety (Thyroid functioning)

Time frame:Baseline through Week 11 (includes Safety Follow-up)

descriptive

Primary/protocol endpoint

Tolerability (Dose Modifications)

Time frame:Baseline up to Week 9

descriptive

Primary/protocol endpoint

Tolerability (Discontinuations)

Time frame:Baseline to Week 9

descriptive

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

Feasibility (Recruitment, Retention)

Time frame:Baseline up to Week 9

threshold achievement, improvement

Primary/protocol endpoint

Feasibility (Visit Completion)

Time frame:Baseline up to Week 9

threshold achievement, improvement

Primary/protocol endpoint

Feasibility (Adherence)

Time frame:Baseline up to Week 9

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.