Lithium for Parkinson's Disease

Overseen By Rachel Shepherd

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: State University of New York at Buffalo

Disqualifiers: Tobacco, THC, Brain surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine the effects of lithium aspartate 30-45mg/day on MRI biomarkers and blood-based therapeutic targets among 15 early-stage Parkinson's disease patients.

Eligibility Criteria

This trial is for early-stage Parkinson's disease patients who haven't used tobacco or THC for over a year, have had stable PD medications and psychiatric/diuretic meds for at least 30-60 days, and no history of lithium therapy. They should not have other medical conditions that could affect the study.

Inclusion Criteria

You have been diagnosed with Parkinson's Disease for less than four years by a movement disorder specialist, and you possess normal thyroid and renal function

I haven't used tobacco or THC for over a year and my Parkinson's disease medication has been stable for over 30 days.

You do not have any medical or mental health issues that could impede study activities, according to the investigator.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lithium aspartate 30-45mg/day for 24 weeks, with dosage titrated to the maximum tolerated level

24 weeks

Baseline and 24-week visits for blood-based biomarkers and MRI assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lithium aspartate

Trial Overview The study tests if low doses of lithium aspartate (30-45mg/day) can impact MRI brain scans and blood markers in people with early-stage Parkinson's Disease. It aims to enroll 15 participants to observe these potential changes.

Participant Groups

Group I: Lithium aspartate Experimental Treatment 1 Intervention

Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+