LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response
In plain words A Phase 1 and 2 study of lithium Orotate in people of any age, run by Johns Hopkins University. It plans to enroll about 40 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people of any age. Conditions: Alzheimer s Disease.
- 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
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Lithium orotate; Matched Placebo (Capsules)
Registered 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… The full summary is on the listing.
Where, as registered
No sites listed yet.