Repurposing Lithium for Parkinson's Disease: a RCT

Last updated: July 4, 2025
Sponsor: State University of New York at Buffalo
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

Lithium

Placebo

Clinical Study ID

NCT06339034
STUDY
  • Ages 40-80
  • All Genders

Study Summary

This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 early-stage Parkinson's disease patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have PD for <4 years diagnosed by a movement disorder specialist. Have normalthyroid and renal function at the screening visit. Have no previous exposure tolithium therapy. Have no history of brain surgery. Have no hx of brain imagingfindings 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

Exclusion Criteria:

  • Have PD for >4 years or does not have PD. Have abnormal normal thyroid and renalfunction at the screening visit. Have previous exposure to lithium therapy. Havehistory of brain surgery. Have hx of brain imaging findings suggesting anotherneurological 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.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Lithium
Phase: 1/2
Study Start date:
July 03, 2024
Estimated Completion Date:
February 28, 2026

Study Description

In observational studies, small daily doses of lithium have been associated with a 77% reduced risk of developing Parkinson's disease (PD). In addition, lithium therapy has been effective in preventing neuronal death and behavioral symptoms in several PD animal models. Recently, our group has shown 24-weeks of low-dose lithium therapy in PD to improve both MRI and blood-based biomarkers implying that lithium may be slowing the progression of the disease. However, these findings stem from only three of four patients receiving MRIs. A larger study will be required to determine if these promising results can be replicated. The proposed study will enroll 20 additional PD patients who will be randomly assigned to receive either lithium 20mg/day or identically-appearing placebo capsules for 24 weeks. This will be a double-blind study meaning that neither the patients nor the study team will know to which therapy patients have been assigned. Positive results from this study will support further research on lithium that could eventually support lithium as a disease-modifying therapy for PD that could improve patients' long-term prognoses.

Connect with a study center

  • UBMD Neurology

    Williamsville, New York 14221
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.