A Phase 1/2 interventional study of Lithium aspartate in Parkinson Disease, sponsored by State University of New York at Buffalo. Enrolling by invitation at 1 site in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by State University of New York at Buffalo · Phase 1/2, Interventional, and Treatment
This study will examine the effects of 24 weeks of lithium therapy achieving serum lithium levels of 0.25-0.50mmol/L on MRI and blood-based biomarkers in Parkinson's disease patients who have completed one of our current 24-week lithium clinical trials.
In observational studies, small daily doses of lithium from smoking cigarettes 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 therapy in PD to be associated with improvements in both MRI and blood-based biomarkers implying that lithium may be slowing the progression of the disease. However, these findings stemmed from only three of four patients receiving MRIs. Our group is now conducting two larger studies enrolling a total of 35 PD patients who are being treated with either 45mg/day or 20mg/day of lithium or placebo therapy for 24 weeks. Because our earlier study showed maximum improvements in PD biomarkers in patients with serum lithium levels of 0.25-0.50mmol/L and there are large interpatient variations in serum lithium levels achieved from the same lithium dosage, this present study will adjust lithium dosing in each patient to achieve this target serum lithium level for an additional 24 weeks. MRI and blood-based biomarker changes from Baseline will be compared in patients with serum lithium levels ≥ 0.25mmol/L and \<0.25mmol/L from one of the 24-week studies and within individual patients. Results from this study may identify a target serum lithium level range associated with maximum improvements in PD biomarkers that can be used in the design of future, larger lithium PD lithium trials, which may eventually support lithium as a disease-modifying therapy for PD that could improve patients' long-term prognoses.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 35 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Lithium aspartate with dosage adjusted to achieve a serum lithium level of 0.25-0.50mmol/L
Dietary Supplement: Lithium aspartate
Lithium aspartate with dosage adjusted to serum lithium level 0.25-0.50mmol/L
Free Water
Change in MRI-assessed free water in posterior substantia nigra, dorsomedial nucleus of the thalamus and nucleus basalts of Meynert.
Time frame: 24 Weeks.
Serum neurofilament light chain
Change in serum neurofilament light chain
Time frame: 24 weeks
Peripheral blood mononuclear cell (PBMC) Nurr1 mRNA levels by real-time polymerase chain reaction (PCR)
Change in PBMC Nurr1
Time frame: 24 weeks
PBMC superoxide dismutase 1 (SOD-1) mRNA levels
Change in PBMC SOD-1
Time frame: 24 weeks
PBMC phosphorylated (p) and total (t) levels of pS9 and total-glycogen synthase kinase 3B (GSK-3B)
Change in PBMC pS9 and t-GSK-3B
Time frame: 24 weeks
PBMC pThr308, pS473 and t-protein kinase B (Akt)
Change in pThr308, pS473 and t-Akt
Time frame: 24 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III
Change in MDS-UPDRS part III scores, Assessed in the "on" state. Score range 0-132 with higher scores indicating worse outcomes.
Time frame: 24 weeks
Parkinson's Anxiety Scale
Change in Parkinson's Anxiety Scale scores, Score range 0-48 with higher scores indicating worse outcomes.
Time frame: 24 weeks
Geriatric Depression Scale-15
Change in Geriatric Depression Scale-15 scores, Score range 0-15 with higher scores indicating worse outcomes.
Time frame: 24 weeks
Fatigue Severity Scale
Change in Fatigue Severity Scale scores, Score range 9-63 with higher scores indicating worse outcomes.
Time frame: 24 weeks
Insomnia Severity Index
Change in Insomnia Severity Index, Score range 0-28 with higher scores indicating worse outcomes.
Time frame: 24 weeks
Parkinson's Disease Questionnaire-8
Change in Parkinson's Disease Questionnaire-8 scores, Score range 0-32 with higher scores indicating worse outcomes.
Time frame: 24 weeks
Montreal Cognitive Assessment (MoCA)
Change in Montreal Cognitive Assessment (MoCA) version 1 and 2 scores, Score range 0-30 with higher scores indicating better outcomes.
Time frame: 24 weeks
Plan to share: Yes — Patient demographics and outcome measure results.
Supporting information: Study protocol, Sap, Icf, Csr
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State University of New York at Buffalo