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Mood Stabilizer

Effects of Lithium Therapy on Blood-based Therapeutic Targets in 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 baseline to weeks 12 and 24.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if low doses of lithium can help treat Parkinson's disease by changing certain chemicals in the blood. The study will involve 18 patients with Parkinson's disease and will last for several months. Researchers hope to find out if lithium can slow down or change the course of the disease. Lithium has recently been suggested to have protective effects on the brain in several models of neurodegenerative diseases including Parkinson's disease.

Eligible Conditions

Parkinson's Disease
Dementia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to weeks 12 and 24.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to weeks 12 and 24.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to weeks 12 and 24. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Fatigue Severity Scale

Geriatric Depression Scale-15

Sleeplessness

+5 more

Side effects data

From 2012 Phase 4 trial • 46 Patients • NCT00596622

33%

headaches

11%

Increased appetite

11%

Drymouth

11%

dizziness

11%

heart palpitations

blurred vision

forgetfulness

bad taste

100%

80%

60%

40%

20%

Study treatment Arm

Bipolar Participants Treated

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Lithium carbonateExperimental Treatment1 Intervention

The dose will be titrated based on weekly blood tests to achieve a target serum level of 0.40-0.50mmol/L, which represents an elemental lithium dose of about 85-170mg a day.

Group II: Lithium aspartate 45mg a dayExperimental Treatment1 Intervention

20mg every morning and 25mg every evening of elemental lithium administered by mouth.

Group III: Lithium aspartate 15mg a dayExperimental Treatment1 Intervention

15mg of elemental lithium administered every morning by mouth.

Group IV: No lithium treatmentActive Control1 Intervention

Control arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lithium

2001