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Lithium aspartate 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from bl to 24 weeks.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MRI-derived free water (FW) levels

Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression.

Secondary outcome measures

Fatigue Severity Scale

Geriatric Depression Scale-15

Insomnia Severity Index

+9 more

Other outcome measures

Adverse events

Side effects data

From 2014 Phase 4 trial • 24 Patients • NCT01507181

58%

Headache

33%

Hospitalizations

17%

Poor concentration

17%

Anxiety

17%

Poor coordination

17%

General malaise

17%

Restlessness

17%

Dizziness on standing

Blurred vision

Difficulty sleeping

Nausea/Vomiting

Constipation

Death

Frequent urination

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

Midazolam

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor

246 Previous Clinical Trials

49,487 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with the therapeutic administration of lithium aspartate?

"Considering that this trial is in its initial Phase 1 stage, the safety of Lithium aspartate is estimated to be at a level of 1. This indicates that there is limited available data supporting both its safety and efficacy."

Answered by AI

Is the study open to individuals who are 80 years of age or older?

"To be considered eligible for this study, interested individuals must fall within the age range of 40 to 80 years. It is noteworthy that there are a total of 20 clinical trials available specifically for participants under the age of 18, while an extensive number of 513 trials cater to patients over the age of 65."

Answered by AI

Are there ongoing efforts to actively enroll participants for this medical study?

"As per the information provided on clinicaltrials.gov, this particular clinical trial is not actively seeking participants. The study was initially posted on October 12th, 2023 and last updated on December 20th, 2023. However, it's important to note that there are currently 517 other trials actively recruiting participants at present."

Answered by AI

What are the primary objectives of this medical study?

"The main objective of this research is to assess the change in MRI-derived free water (FW) levels from baseline to 24 weeks. Secondary measurements include levodopa equivalent dose, which reflects the dosage of dopaminergic therapy administered and higher scores indicating a greater dose; Insomnia Severity Index, scored on a range of 0-28 with higher values indicating more severe symptoms; and PBMC superoxide dismutase type-1 (SOD-1) mRNA expression, measured through Taqman PCR analysis for evaluating PBMC SOD-1 mRNA expression levels."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Repurposing Lithium for Parkinson's Disease

Thomas Guttuso 2023. "Repurposing Lithium for Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06099886.