Lithium for Parkinson's Disease

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: State University of New York at Buffalo

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

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

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

Treatment Details

Interventions

• Lithium (Other)

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

Group I: Lithium aspartate Experimental Treatment 1 Intervention

Lithium aspartate with dosage adjusted to achieve a serum lithium level of 0.25-0.50mmol/L

Lithium is already approved in Canada, Japan for the following indications:

Approved in Canada as Lithium for:

• Bipolar disorder
• Manic episodes
• Major depressive disorder

Approved in Japan as Lithium for:

• Bipolar disorder
• Manic episodes

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+