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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lithium aspartate (a form of lithium) can aid early-stage Parkinson's disease by examining changes in brain scans and specific blood markers. The study aims to determine if this treatment can provide new insights or improvements in managing Parkinson's. Ideal participants are those diagnosed with Parkinson's within the last four years, who have not taken lithium before, and have stable health conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

You don't need to stop your current medications, but they must be stable. Your Parkinson's medications should not have changed in the last 30 days, and your psychiatric and diuretic medications should not have changed in the last 60 days.

Is there any evidence suggesting that lithium aspartate is likely to be safe for humans?

Research has shown that lithium aspartate might be safe for people with Parkinson's disease, but certain considerations are important. In earlier studies, patients taking medium doses of lithium aspartate experienced positive changes in blood tests and MRI scans, suggesting potential benefits for Parkinson's disease. However, not everyone may tolerate these doses well.

Another study found that small daily doses of lithium were linked to a lower risk of developing Parkinson's disease, indicating safety in small amounts.

These findings are encouraging, but as this is a Phase 1 trial, researchers are just beginning to assess the safety of this treatment in humans. More studies are needed to understand how people with Parkinson's disease will respond to lithium aspartate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Unlike the standard treatments for Parkinson's disease, which typically include medications like levodopa that increase dopamine levels or drugs that mimic dopamine, lithium aspartate offers a new approach. Lithium aspartate is unique because it is believed to have neuroprotective properties, which might help slow the progression of Parkinson’s disease by protecting brain cells. Researchers are excited about this treatment because it could offer benefits beyond symptom management, potentially altering the disease's course, which existing treatments do not.

What evidence suggests that lithium aspartate might be an effective treatment for Parkinson's disease?

Research has shown that lithium can protect nerve cells from damage. It proved effective in animal studies of Parkinson's disease, suggesting it might reduce symptoms. Observational studies have also found that small doses of lithium are linked to a 77% lower risk of developing Parkinson's disease. This trial will study lithium aspartate, which could help manage Parkinson's disease by targeting specific brain areas. However, more research is needed to confirm its effectiveness in humans. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10196787/

Lithium's effects on therapeutic targets and MRI biomarkers ... Lithium has a wide range of neuroprotective actions, has been effective in Parkinson's disease (PD) animal models and may account for the decreased risk of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06592014

Study Details | NCT06592014 | Lithium for Parkinson's In observational studies, small daily doses of lithium from smoking cigarettes have been associated with a 77% reduced risk of developing Parkinson's disease ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667242123000398

Lithium's effects on therapeutic targets and MRI biomarkers ... Lithium has a wide range of neuroprotective actions, has been effective in Parkinson's disease (PD) animal models and may account for the decreased risk of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06099886

Repurposing Lithium for Parkinson's Disease In observational studies, small daily doses of lithium have been associated with a 77% reduced risk of developing Parkinson's disease (PD).

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824334

Lithium Aspartate for Long COVID Fatigue and Cognitive ... The randomized, double-blind, placebo-controlled trial showed therapy with lithium aspartate, 10 to 15 mg/d, to be ineffective for treating PCC ...

6. medrxiv.org medrxiv.org/content/10.1101/2025.03.04.25323314v1.full.pdf

Lithium's effects on serum neurofilament light in ... Conclusions: Lithium therapy achieving serum levels 0.21-0.56mmol/L significantly reduced serum NfL in PD, which strongly supports further ...

7. hmpgloballearningnetwork.com hmpgloballearningnetwork.com/site/altc/news/medium-dose-lithium-may-hit-parkinson-disease-targets-tolerability-questioned

Medium-Dose Lithium May Hit Parkinson Disease Targets ... Medium-dose lithium aspartate therapy was associated with increases in blood-based targets and improvements in disease-progression biomarkers ...