Trial Outcomes & Findings for Repurposing Lithium for Parkinson's Disease (NCT NCT06099886)

NCT ID: NCT06099886

Last Updated: 2026-05-13

Results Overview

FW in the posterior substantia nigra (pSN), dorsomedial nucleus of the thalamus (DMN-T) and the nucleus basalts of Meynert (nbM).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Change from baseline (BL) to 24 weeks.

Results posted on

2026-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Lithium Aspartate Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repurposing Lithium for Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Age, Continuous	65.2 years STANDARD_DEVIATION 6.8 • n=1512 Participants
Sex: Female, Male Female	8 Participants n=1512 Participants
Sex: Female, Male Male	7 Participants n=1512 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1512 Participants
Race (NIH/OMB) Asian	0 Participants n=1512 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants
Race (NIH/OMB) Black or African American	0 Participants n=1512 Participants
Race (NIH/OMB) White	15 Participants n=1512 Participants
Race (NIH/OMB) More than one race	0 Participants n=1512 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1512 Participants
Region of Enrollment United States	15 participants n=1512 Participants

PRIMARY outcome

Timeframe: Change from baseline (BL) to 24 weeks.

FW in the posterior substantia nigra (pSN), dorsomedial nucleus of the thalamus (DMN-T) and the nucleus basalts of Meynert (nbM).

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
MRI-derived Free Water (FW) Levels % change in pSN FW	7.9 % change Standard Deviation 89.5
MRI-derived Free Water (FW) Levels % change in nbM FW	-3.8 % change Standard Deviation 14.6
MRI-derived Free Water (FW) Levels % change in DMN-T FW	1.5 % change Standard Deviation 8.3

PRIMARY outcome

Timeframe: Change from BL to 24 weeks.

PBMC Nurr1 mRNA expression using Taqman PCR.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=13 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Peripheral Blood Mononuclear Cell (PBMC) Nuclear Receptor-related 1 Protein (Nurr1) mRNA Expression.	143.4 % change Standard Deviation 386.8

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease patients

Assessed using SIMOA platform

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Serum Neurofilament Light (NfL)	-3.6 percent change from baseline Standard Deviation 20.8

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Assessed using SIMOA platform

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Serum Glial Fibrillary Acidic Protein (GFAP)	35 percent change from baseline Standard Deviation 114

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

PBMC SOD-1 mRNA expression using Taqman PCR.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=13 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
PBMC Superoxide Dismutase Type-1 (SOD-1) mRNA Expression	5.2 Percent change from baseline Standard Deviation 58.5

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Assessed using ELISA

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=10 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
PBMC pS9/Total Glycogen Synthase Kinase-3B (GSK-3B) Ratio	4.7 percent change from baseline Standard Deviation 19.7

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Assessed using ELISA

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=5 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
PBMC pThr308 and pS473/Total Protein Kinase B (Akt) Ratios % change from BL, pThr308/total Akt	-2.3 % change from BL Standard Deviation 32.1
PBMC pThr308 and pS473/Total Protein Kinase B (Akt) Ratios % change from BL, pS473/total Akt	19.2 % change from BL Standard Deviation 57.3

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Assessed in the "on" state, which is when a patient perceives their Parkinson's medications are kicked in and providing symptomatic benefit. Score range 0-132 with higher scores indicating worse outcomes.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)	4 Change in raw score from BL Standard Deviation 6.9

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Score range 0-30 with higher scores indicating better outcomes.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Montreal Cognitive Assessment (MoCA)	-1 Change in Raw score from BL Standard Deviation 1.61

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Score range 0-48 with higher scores indicating worse outcomes.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Parkinson's Anxiety Scale	0 Change in raw score from BL Standard Deviation 4.33

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Score range 0-15 with higher scores indicating worse outcomes.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Geriatric Depression Scale-15	0 Change in raw score from BL Standard Deviation 2.70

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Score range 9-63 with higher scores indicating worse outcomes.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Fatigue Severity Scale	3 Change in raw score from BL Standard Deviation 9.37

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Score range 0-28 with higher scores indicating worse outcomes.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Insomnia Severity Index	0 Change in raw score from BL Standard Deviation 1.93

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Score range 0-32 with higher scores indicating worse outcomes.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Parkinson's Disease Questionnaire-8	0 Change in raw score from BL Standard Deviation 3.85

SECONDARY outcome

Timeframe: Change from BL to 24 weeks.

Population: Parkinson's disease

Higher scores indicate higher dose of dopaminergic therapy.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Levodopa Equilavent Dose	0 mg levodopa equivalent Standard Deviation 76.69

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 24 weeks.

Population: Parkinson's disease

Number of patients with serious adverse events and number who withdraw from the study.

Outcome measures

Outcome measures
Measure	Lithium Aspartate n=15 Participants Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Adverse Events Serious adverse events	0 Participants
Adverse Events Patient withdraws	0 Participants
Adverse Events No adverse events	11 Participants
Adverse Events Sedation	2 Participants
Adverse Events Nausea	1 Participants
Adverse Events Dyskinesia	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 24

Population: Parkinson's disease

Interleukin-6

Outcome measures

Outcome data not reported

Adverse Events

Lithium Aspartate

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lithium Aspartate n=15 participants at risk Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day. Lithium aspartate: Lithium aspartate 30-45mg/day
Nervous system disorders Sedation	13.3% 2/15 • 24 weeks
Gastrointestinal disorders Nausea	6.7% 1/15 • 24 weeks
Nervous system disorders Dyskinesias	6.7% 1/15 • 24 weeks

Additional Information

Thomas Guttuso, MD

SUNY Buffalo

Phone: 7169326080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place