Status:
COMPLETED
Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-80 years
Phase:
PHASE1
Brief Summary
This study aims to determine if one of three low doses of lithium therapy for 6 months can engage one or more blood-based therapeutic targets implicated in Parkinson's disease (PD) pathophysiology. Re...
Detailed Description
Lithium belongs to a class of kinase-targeting therapies, including the diabetes medication exenatide and the cancer medication nilotinib, that have demonstrated promise as disease-modifying therapies...
Eligibility Criteria
Inclusion
- Diagnosed with PD according to the UK Brain Bank Criteria.
- 45-80yo.
- Clinical Dementia Rating Scale score of 0 or 0.5.
- Stable PD medications for previous 30 days and no current need for changes in the opinion of the PI.
- No formed visual hallucinations or delusions for previous year.
- Never taken prescription or over-the-counter lithium.
- Stable or no diuretics for past 4 weeks and no need for changes for at least 6 months, in the PI's opinion.
- Stable doses of antidepressants, antihypertensives and non-steroidal anti-inflammatory medications (NSAIDs) for previous 60 days and no current need to adjust such medications.
- No history of cardiac arrhythmias besides atrial fibrillation that is rate controlled.
- No unstable cardiac, medical or psychiatric condition in the opinion of the PI.
- No current use of illicit drugs or current alcohol abuse in the opinion of the PI.
- No history of hypothyroidism, not receiving thyroid replacement therapy and normal thyroid stimulating hormone (TSH) level at screening visit.
- Estimated renal glomerular filtration rate ≥50 at screening visit.
- No history of receiving or planning to receive nilotinib or a glucagon-like peptide-1 agonist medication such as exenatide.
- No use of tobacco products for the previous year.
- No deep brain stimulation (DBS) or possible need for DBS for at least 1-year in the opinion of the PI.
- Women with child bearing potential will need a negative pregnancy test and not be nursing an infant at screening. Women with child bearing potential will need to report using barrier method or hormonal contraception.
- Not enrolled in another clinical trial.
- Willing and able to sign informed consent and follow study procedures.
Exclusion
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04273932
Start Date
October 17 2019
End Date
August 12 2023
Last Update
August 15 2023
Active Locations (1)
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1
University at Buffalo
Williamsville, New York, United States, 14221