Clinical trial
Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.
Name
STUDY00003688
Description
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. Results of this study will help to determine if lithium therapy is worthwhile to further investigate as a potential disease-modifying therapy in PD, the optimal dose to study and the optimal PD subgroup most likely to benefit from lithium therapy.
Trial arms
Trial start
2019-10-17
Estimated PCD
2023-06-15
Trial end
2023-08-12
Status
Completed
Phase
Early phase I
Treatment
Lithium
Lithium aspartate of lithium carbonate will be administered by mouth.
Arms:
Lithium aspartate 15mg a day, Lithium aspartate 45mg a day, Lithium carbonate
Size
19
Primary endpoint
Plasma alpha-synuclein assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ).
Change from baseline to 24 weeks
Peripheral blood mononuclear cell (PBMC) Nurr1 mRNA levels by real-time polymerase chain reaction.
Change from baseline to 24 weeks
PBMC phosphorylated (p) and total (t) levels of pSerine9 and t-glycogen synthase kinase-3B
Change from baseline to 24 weeks
Plasma brain-derived neurotrophic factor (BDNF).
Change from baseline to 24 weeks
PBMC pThreonine308 and t-protein kinase B (Akt).
Change from baseline to 24 weeks
Eligibility criteria
1. Diagnosed with PD according to the UK Brain Bank Criteria.
2. 45-80yo.
3. Clinical Dementia Rating Scale score of 0 or 0.5.
4. Stable PD medications for previous 30 days and no current need for changes in the opinion of the PI.
5. No formed visual hallucinations or delusions for previous year.
6. Never taken prescription or over-the-counter lithium.
7. Stable or no diuretics for past 4 weeks and no need for changes for at least 6 months, in the PI's opinion.
8. Stable doses of antidepressants, antihypertensives and non-steroidal anti-inflammatory medications (NSAIDs) for previous 60 days and no current need to adjust such medications.
9. No history of cardiac arrhythmias besides atrial fibrillation that is rate controlled.
10. No unstable cardiac, medical or psychiatric condition in the opinion of the PI.
11. No current use of illicit drugs or current alcohol abuse in the opinion of the PI.
12. No history of hypothyroidism, not receiving thyroid replacement therapy and normal thyroid stimulating hormone (TSH) level at screening visit.
13. Estimated renal glomerular filtration rate ≥50 at screening visit.
14. No history of receiving or planning to receive nilotinib or a glucagon-like peptide-1 agonist medication such as exenatide.
15. No use of tobacco products for the previous year.
16. No deep brain stimulation (DBS) or possible need for DBS for at least 1-year in the opinion of the PI.
17. 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.
18. Not enrolled in another clinical trial.
19. Willing and able to sign informed consent and follow study procedures.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, parallel group, open-label trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-08-15
1 organization
1 product
1 indication
Organization
State University of New York at BuffaloProduct
LithiumIndication
Parkinson's disease