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Lithium for Parkinson's Disease

Phase 1
Waitlist Available
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from bl to 24 weeks.
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate how taking 30-45mg of lithium aspartate per day affects the brain scans and blood markers of 15 patients with early-stage Parkinson's disease.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, common side effects of lithium may include increased thirst, hand tremors, frequent urination, mild nausea or diarrhea. Each person might experience side effects differently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from bl to 24 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from bl to 24 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MRI-derived free water (FW) levels
Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression.
Secondary study objectives
Fatigue Severity Scale
Geriatric Depression Scale-15
Insomnia Severity Index
+9 more
Other study objectives
Adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lithium aspartateExperimental Treatment1 Intervention
Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day.

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
365 Previous Clinical Trials
412,599 Total Patients Enrolled
State University of New York at BuffaloLead Sponsor
268 Previous Clinical Trials
52,315 Total Patients Enrolled
~2 spots leftby Feb 2025
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