Repurposing Lithium for Parkinson's Disease

Status Enrolling by invitation

Clinical Trial Summary

This study will examine the effects of lithium aspartate 30-45mg/day on MRI biomarkers and blood-based therapeutic targets among 15 early-stage Parkinson's disease patients.

Clinical Trial Description

In observational studies, small daily doses of lithium have been associated with a 77% reduced risk of developing Parkinson's disease (PD). In addition, lithium therapy has been effective in preventing neuronal death and behavioral symptoms in several PD animal models. Recently, our group has shown 24-weeks of low-dose lithium aspartate therapy 45mg/day in PD to engage blood-based and the MRI disease progression biomarker, free water, to a greater extent than 15mg/day or 150mg/day of lithium carbonate. However, these blood-based and MRI biomarker findings stem from only four and two PD patients, respectively, who received lithium aspartate 45mg/day. In addition, two other PD patients receiving this dosage withdrew from the study due to side effects of sedation and dizziness. Subsequently, one of these patients who withdrew resumed lithium aspartate at 30mg/day and reported no side effects. Although these findings suggest that this dosage of lithium aspartate has positive effects on PD biomarkers, data from a larger number of PD patients will be required to justify conducting a larger, randomized controlled trial (RCT). The proposed study will enroll 15 additional PD patients over five months who will receive lithium aspartate 30-45mg/day for 24 weeks ensuring that the study will be completed within 12 months. The dosage will be slowly titrated in each patient up to the maximum tolerated dosage in this range. Blood-based biomarkers and MRIs will be assessed at baseline and 24 weeks. It is anticipated that a similar magnitude of biomarker engagement will be observed among these additional 15 patients as was seen in the handful from the pilot study. Such findings would provide strong preliminary evidence to support conducting a larger RCT including both clinical and biomarker outcomes. Positive results from such a RCT would support lithium aspartate as a disease-modifying therapy for PD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06099886
Study type	Interventional
Source	State University of New York at Buffalo
Contact
Status	Enrolling by invitation
Phase	Phase 1
Start date	October 12, 2023
Completion date	May 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02915848` - Long-term Stability of LFP Recorded From the STN and the Effects of DBS
Recruiting	`NCT03648905` - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Terminated	`NCT02688465` - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).	Phase 4
Completed	`NCT05040048` - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Active, not recruiting	`NCT04006210` - Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations	Phase 3
Completed	`NCT02562768` - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease	Phase 1
Completed	`NCT00105521` - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia	Phase 3
Completed	`NCT00105508` - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia	Phase 3
Recruiting	`NCT06002581` - Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease	N/A
Completed	`NCT02236260` - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation	N/A
Completed	`NCT00529724` - Body Weight Gain, Parkinson, Subthalamic Stimulation	Phase 2
Active, not recruiting	`NCT05699460` - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Completed	`NCT03703570` - A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations	Phase 2
Completed	`NCT03462680` - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures	N/A
Completed	`NCT02837172` - Diagnosis of PD and PD Progression Using DWI
Not yet recruiting	`NCT04046276` - Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease	N/A
Recruiting	`NCT02952391` - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol	N/A
Active, not recruiting	`NCT02937324` - The CloudUPDRS Smartphone Software in Parkinson's Study.	N/A
Completed	`NCT02939391` - A Study of KW-6356 in Subjects With Early Parkinson's Disease	Phase 2
Completed	`NCT02874274` - Vaccination Uptake (VAX) in PD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.