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Mood Stabilizer

Lithium aspartate 15mg a day 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
No formed visual hallucinations or delusions for previous year.
No history of receiving or planning to receive nilotinib or a glucagon-like peptide-1 agonist medication such as exenatide.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to weeks 12 and 24.
Awards & highlights

Study Summary

This trial is testing if low doses of lithium can help treat Parkinson's by engaging certain blood-based targets involved in the disease. Results will help researchers determine if lithium is worth further investigating, what dose is most effective, and in which patients it is most helpful.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have not experienced seeing or hearing things or having false beliefs for the past year.
Select...
You have not taken, and will not take, a medication called nilotinib or a type of medication for diabetes called exenatide.
Select...
You have never taken prescribed or over-the-counter lithium medication.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PBMC pThreonine308 and t-protein kinase B (Akt).
PBMC phosphorylated (p) and total (t) levels of pSerine9 and t-glycogen synthase kinase-3B
Peripheral blood mononuclear cell (PBMC) Nurr1 mRNA levels by real-time polymerase chain reaction.
+2 more
Secondary outcome measures
Fatigue Severity Scale
Geriatric Depression Scale-15
Sleeplessness
+6 more

Side effects data

From 2012 Phase 4 trial • 46 Patients • NCT00596622
33%
headaches
11%
Drymouth
11%
dizziness
11%
heart palpitations
11%
Increased appetite
7%
forgetfulness
7%
bad taste
7%
blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bipolar Participants Treated

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
Completed Phase 4
~2470

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
244 Previous Clinical Trials
49,438 Total Patients Enrolled
University at BuffaloLead Sponsor
130 Previous Clinical Trials
98,865 Total Patients Enrolled

Frequently Asked Questions

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

Does the study accept participants below the age of 30?

"This clinical trial specifies that study participants must be aged 45 to 80. In contrast, there are 29 medical studies for individuals below the age of majority and 489 trials recruiting persons over 65 years old."

Answered by AI

Are there any remaining slots accessible to participants in this trial?

"According to the information on clinicaltrials.gov, recruitment for this study is not currently taking place. This trial was initially posted on October 17th 2019 and last updated September 30th 2022. Despite being inactive, there are still 495 other studies recruiting participants at present time."

Answered by AI

Has the FDA endorsed a dosage of 15mg Lithium aspartate per day?

"Due to the limited information available of lithium aspartate 15mg a day, our team at Power has rated its safety a 1 out of 3. This is typical for Phase 1 trials which have minimal data on efficacy and security."

Answered by AI

Am I eligible to participate in this trial?

"Eligibility requirements mandate that individuals with parkinson's disease between the ages of 45 and 80 may join. Aspiring participants must also meet other criteria, as 19 slots are available in total."

Answered by AI

What is the current cap on participant enrollment for this experiment?

"This medical trial has reached the end of its recruitment period, having first been posted on October 17th 2019 and last updated September 30th 2022. However, presently there are 485 clinical trials recruiting patients with Parkinson's disease as well as 10 studies for Lithium Aspartate 15mg a day that require participants."

Answered by AI
~4 spots leftby Mar 2025