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Lithium for Parkinson's Disease
Phase 1 & 2
Recruiting
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 throughout 24 week study
Summary
This trial will investigate how taking lithium 20mg/day affects MRI scans and blood tests in 20 people with early-stage Parkinson's disease, compared to those who take a placebo.
Who is the study for?
This trial is for early-stage Parkinson's disease patients who haven't used lithium before and have no other neurological conditions. Participants should not be tobacco or THC users, must have stable PD medications for over a month, and cannot have any active medical issues that could affect the study.
What is being tested?
The study is testing if a low dose of lithium (20mg/day) can impact MRI and blood biomarkers in Parkinson's disease compared to a placebo. It involves 20 participants with early-stage PD to see if there are any benefits.
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; however individual experiences may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout 24 week study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout 24 week study
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
Serum neurofilament light chain (NfL)
Secondary study objectives
Fatigue Severity Scale
Geriatric Depression Scale-15
Insomnia Severity Index
+10 moreOther study objectives
Adverse events
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: LithiumActive Control1 Intervention
Lithium: 10mg, 2x/day
Group II: PlaceboPlacebo Group1 Intervention
Identical capsules filled with cellulose: 10mg, 2x/day
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Who is running the clinical trial?
State University of New York at BuffaloLead Sponsor
268 Previous Clinical Trials
52,310 Total Patients Enrolled
The Cure Parkinson's TrustUNKNOWN
2 Previous Clinical Trials
86 Total Patients Enrolled
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