Repurposing Lithium for Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT06099886 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lithium aspartate (Dietary_supplement)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MRI-derived Free Water (FW) Levels |
7.9; -3.8; 1.5 | — |
| PRIMARY Peripheral Blood Mononuclear Cell (PBMC) Nuclear Receptor-related 1 Protein (Nurr1) mRNA Expression. |
143.4 | — |
| SECONDARY Serum Neurofilament Light (NfL) |
-3.6 | — |
| SECONDARY Serum Glial Fibrillary Acidic Protein (GFAP) |
35 | — |
| SECONDARY PBMC Superoxide Dismutase Type-1 (SOD-1) mRNA Expression |
5.2 | — |
| SECONDARY PBMC pS9/Total Glycogen Synthase Kinase-3B (GSK-3B) Ratio |
4.7 | — |
| SECONDARY PBMC pThr308 and pS473/Total Protein Kinase B (Akt) Ratios |
-2.3; 19.2 | — |
| SECONDARY Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) |
4 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
-1 | — |
| SECONDARY Parkinson's Anxiety Scale |
— | — |
| SECONDARY Geriatric Depression Scale-15 |
— | — |
| SECONDARY Fatigue Severity Scale |
3 | — |
| SECONDARY Insomnia Severity Index |
— | — |
| SECONDARY Parkinson's Disease Questionnaire-8 |
— | — |
| SECONDARY Levodopa Equilavent Dose |
— | — |
Summary
Eligibility Criteria
Inclusion Criteria
Have PD for 1 year. Have stable PD medications for >30 days without current need for adjustments in the investigator's opinion.
Have stable psychiatric and diuretic medications for >60 days with no anticipated need for changes for at least 24 weeks.
Have no active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion.
Exclusion Criteria
Have PD for >4 years or does not have PD. Have abnormal normal thyroid and renal function at the screening visit. Have previous exposure to lithium therapy. Have history of brain surgery. Have hx of brain imaging findings suggesting another neurological condition besides PD.
Have use of tobacco or THC products within the past year. Have PD medication adjustments within 30 days or needs PD medication adjustments in the investigator's opinion.
Have psychiatric or diuretic medication adjustments within the last 60 days or is anticipated to need changes over next 24 weeks.
Have active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion.
Data sourced from ClinicalTrials.gov (NCT06099886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.