Using Lithium to Treat Early Parkinson's Disease
Repurposing Lithium as a Disease-modifying Therapy in Parkinson's Disease: A Randomized Controlled Trial
This study is testing if taking a daily dose of lithium can help slow down early Parkinson's disease and improve health outcomes for patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Williamsville, New York) |
| Trial ID | NCT06339034 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a daily dose of lithium compared to a placebo on MRI and blood biomarkers in early-stage Parkinson's disease patients. It aims to build on previous findings that suggest low-dose lithium may slow disease progression and improve patient outcomes. The study will enroll 20 participants who will be randomly assigned to receive either lithium or placebo for 24 weeks in a double-blind manner, ensuring unbiased results. The goal is to determine if lithium can be established as a disease-modifying therapy for Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Parkinson's disease for less than four years, with stable medication regimens and no prior exposure to lithium.
Not a fit: Patients with Parkinson's disease for more than four years or those with abnormal thyroid or renal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that slows the progression of Parkinson's disease and improves long-term patient outcomes.
How similar studies have performed: Previous observational studies have shown promising results with low-dose lithium in Parkinson's disease, but this study aims to confirm those findings in a larger, randomized setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have PD for \<4 years diagnosed by a movement disorder specialist. Have normal thyroid and renal function at the screening visit. Have no previous exposure to lithium therapy. Have no history of brain surgery. Have no hx of brain imaging findings suggesting another neurological condition besides PD. Have no use of tobacco or THC products 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.
Where this trial is running
Williamsville, New York
- UBMD Neurology — Williamsville, New York, United States (Recruiting)
Study contacts
- Study coordinator: Thomas Guttuso, MD
- Email: tguttuso@buffalo.edu
- Phone: 716-932-6080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.