Repurposing Lithium for Parkinson's Disease

NCT06099886 | Completed Phase 1 Results

• 2 other identifiers: STUDY00007253UL1TR001412
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects of lithium aspartate 30-45mg/day on MRI biomarkers and blood-based therapeutic targets among 15 early-stage Parkinson's disease patients.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• MRI-derived Free Water (FW) Levels

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

  Change from baseline (BL) to 24 weeks.

• Peripheral Blood Mononuclear Cell (PBMC) Nuclear Receptor-related 1 Protein (Nurr1) mRNA Expression.

  PBMC Nurr1 mRNA expression using Taqman PCR.

  Change from BL to 24 weeks.

Secondary Outcomes (13)

• Serum Neurofilament Light (NfL)

  Change from BL to 24 weeks.

• Serum Glial Fibrillary Acidic Protein (GFAP)

  Change from BL to 24 weeks.

• PBMC Superoxide Dismutase Type-1 (SOD-1) mRNA Expression

  Change from BL to 24 weeks.

• PBMC pS9/Total Glycogen Synthase Kinase-3B (GSK-3B) Ratio

  Change from BL to 24 weeks.

• PBMC pThr308 and pS473/Total Protein Kinase B (Akt) Ratios

  Change from BL to 24 weeks.

Other Outcomes (2)

• Adverse Events

  Through study completion, an average of 24 weeks.

• Serum IL-6

  Change from Baseline to Week 24

Study Arms (1)

Lithium aspartate

EXPERIMENTAL

Lithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day.

Dietary Supplement: Lithium aspartate

Interventions

Lithium aspartate DIETARY_SUPPLEMENT

Lithium aspartate 30-45mg/day

Also known as: Lithitate

Lithium aspartate

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have PD for \<4 years diagnosed by a movement disorder specialist. Have normal thyroid and renal function at the screening visit. Have no previous exposure to lithium therapy. Have no history of brain surgery. Have no hx of brain imaging findings suggesting another neurological condition besides PD.
• Have no use of tobacco or THC products for \>1 year. Have stable PD medications for \>30 days without current need for adjustments in the investigator's opinion.
• Have stable psychiatric and diuretic medications for \>60 days with no anticipated need for changes for at least 24 weeks.
• Have no active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion.

You may not qualify if:

• Have PD for \>4 years or does not have PD. Have abnormal normal thyroid and renal function at the screening visit. Have previous exposure to lithium therapy. Have history of brain surgery. Have hx of brain imaging findings suggesting another neurological condition besides PD.
• Have use of tobacco or THC products within the past year. Have PD medication adjustments within 30 days or needs PD medication adjustments in the investigator's opinion.
• Have psychiatric or diuretic medication adjustments within the last 60 days or is anticipated to need changes over next 24 weeks.
• Have active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University at Buffalo

Williamsville, New York, 14221, United States

Location

Related Publications (1)

• Guttuso T Jr, Shepherd R, Frick L, Feltri ML, Frerichs V, Ramanathan M, Zivadinov R, Bergsland N. Lithium's effects on therapeutic targets and MRI biomarkers in Parkinson's disease: A pilot clinical trial. IBRO Neurosci Rep. 2023 May 7;14:429-434. doi: 10.1016/j.ibneur.2023.05.001. eCollection 2023 Jun.

  PMID: 37215748 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Thomas Guttuso, MD
• Organization: SUNY Buffalo

tguttuso@buffalo.edu

7169326080

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: October 25, 2023
• Study Start: October 12, 2023
• Primary Completion: December 6, 2024
• Study Completion: April 30, 2025
• Last Updated: May 13, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)