35 Participants Needed

Lithium for Parkinson's Disease

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: State University of New York at Buffalo
Must be taking: Lithium
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is lithium generally safe for humans?

Research on lithium in animals suggests it may protect against certain brain injuries, but this doesn't directly address its safety in humans. More specific human studies are needed to confirm its safety.12345

How does the drug lithium differ from other treatments for Parkinson's disease?

Lithium, particularly in the form of lithium ascorbate, may offer neuroprotective benefits by supporting neuron survival and reducing brain damage, which is different from traditional Parkinson's treatments that primarily focus on managing motor symptoms. However, lithium can cause side effects like tremors and parkinsonism, especially at higher doses, which requires careful monitoring.678910

What is the purpose of this trial?

This study will examine the effects of 24 weeks of lithium therapy achieving serum lithium levels of 0.25-0.50mmol/L on MRI and blood-based biomarkers in Parkinson's disease patients who have completed one of our current 24-week lithium clinical trials.

Research Team

TG

Thomas Guttuso, MD

Principal Investigator

University at Buffalo

Eligibility Criteria

This trial is for Parkinson's disease patients who have already completed a 24-week lithium clinical trial. It aims to further investigate the effects of lithium therapy on certain biomarkers.

Inclusion Criteria

All PD patients completing STUDY00007253 or STUDY00008239 at the University at Buffalo will be eligible

Exclusion Criteria

Willing and able to sign informed consent and follow study procedures
I am not pregnant, not nursing, and use contraception.
No unstable cardiac, medical, neurologic or psychiatric condition in the opinion of the PI
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lithium therapy with dosage adjusted to achieve a serum lithium level of 0.25-0.50mmol/L for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive lithium therapy to maintain target serum lithium levels for an additional 24 weeks

24 weeks

Treatment Details

Interventions

  • Lithium
Trial Overview The study tests the impact of a 24-week course of lithium aspartate, aiming for specific low serum levels, on MRI and blood-based markers in Parkinson's patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Lithium aspartateExperimental Treatment1 Intervention
Lithium aspartate with dosage adjusted to achieve a serum lithium level of 0.25-0.50mmol/L

Lithium is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Lithium for:
  • Bipolar disorder
  • Manic episodes
  • Major depressive disorder
🇺🇸
Approved in United States as Lithium for:
  • Bipolar disorder
  • Manic episodes
🇨🇦
Approved in Canada as Lithium for:
  • Bipolar disorder
  • Manic episodes
  • Major depressive disorder
🇯🇵
Approved in Japan as Lithium for:
  • Bipolar disorder
  • Manic episodes

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

Findings from Research

In a study using male Wistar rats with brain cholinergic lesions induced by ibotenic acid, lithium treatment significantly reduced behavioral deficits and improved choline acetyltransferase activity in the affected cortex.
The results suggest that lithium may offer protective effects against neurotoxicity caused by excitatory amino acids, indicating its potential therapeutic role in similar neurological conditions.
A protective effect of lithium on rat behaviour altered by ibotenic acid lesions of the basal forebrain cholinergic system.Pascual, T., Gonzalez, JL.[2019]
In a study involving 20 patients with Parkinson's disease, lisuride was well-tolerated at doses up to 5 mg daily, showing significant improvements in symptoms like akinesia, rigidity, and tremor.
While lisuride had similar side effects to other Parkinson's treatments like levodopa and bromocriptine, it was associated with a higher incidence of somnolence (drowsiness).
Lisuride in parkinsonism.Gopinathan, G., Teräväinen, H., Dambrosia, JM., et al.[2019]
In a study involving 10 patients with severe Parkinsonism, lisuride was successfully used to completely replace bromocriptine in all cases, demonstrating its potential as an effective alternative treatment.
Lisuride has similar antiparkinsonian effects to bromocriptine and levodopa, but its short duration of action and common side effects highlight the need for careful management, although it may be particularly useful in emergency situations.
Lisuride in the treatment of Parkinsonism.Schachter, M., Sheehy, MP., Parkes, JD., et al.[2019]

References

A protective effect of lithium on rat behaviour altered by ibotenic acid lesions of the basal forebrain cholinergic system. [2019]
Lisuride in parkinsonism. [2019]
Lisuride in the treatment of Parkinsonism. [2019]
Safety and effectiveness of levodopa-carbidopa intestinal gel for advanced Parkinson's disease: A large single-center study. [2021]
Cost-Effectiveness of Carbidopa-Levodopa Enteral Suspension for Advanced Parkinson's Disease in the United States. [2023]
Lithium Ascorbate as a Promising Neuroprotector: Fundamental and Experimental Studies of an Organic Lithium Salt. [2023]
The Use of Liquid Sinemet in Routine Clinical Practice of Advanced Parkinson's Disease: A Comparison of Available Options. [2023]
Physiological characteristics of tremor after chronic lithium therapy. [2019]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Lithium Cholesterol Sulfate: A Novel and Potential Drug for Treating Alzheimer's Disease and Autism Spectrum Disorder. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Disabling parkinsonism due to lithium: a case report. [2017]
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