AzTrials
AzTrials

Parkinson's DiseasePhase 1NCT06099886

Repurposing Lithium for Parkinson's Disease

A Phase 1 study testing Lithium aspartate in people with Parkinson's Disease, run by State University of New York at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Lithium aspartate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
12 Oct 2023to 30 Apr 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University at Buffalo

    Williamsville, New York, 14221

Other trials in United States

About this study

Official title: Repurposing Lithium as a Disease-modifying Therapy in Parkinson's Disease: A Phase I Trial

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.

Read the detailed description

In observational studies, small daily doses of lithium 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 aspartate therapy 45mg/day in PD to engage blood-based and the MRI disease progression biomarker, free water, to a greater extent than 15mg/day or 150mg/day of lithium carbonate. However, these blood-based and MRI biomarker findings stem from only four and two PD patients, respectively, who received lithium aspartate 45mg/day. In addition, two other PD patients receiving this dosage withdrew from the study due to side effects of sedation and dizziness. Subsequently, one of these patients who withdrew resumed lithium aspartate at 30mg/day and reported no side effects. Although these findings suggest that this dosage of lithium aspartate has positive effects on PD biomarkers, data from a larger number of PD patients will be required to justify conducting a larger, randomized controlled trial (RCT). The proposed study will enroll 15 additional PD patients over five months who will receive lithium aspartate 30-45mg/day for 24 weeks ensuring that the study will be completed within 12 months. The dosage will be slowly titrated in each patient up to the maximum tolerated dosage in this range. Blood-based biomarkers and MRIs will be assessed at baseline and 24 weeks. It is anticipated that a similar magnitude of biomarker engagement will be observed among these additional 15 patients as was seen in the handful from the pilot study. Such findings would provide strong preliminary evidence to support conducting a larger RCT including both clinical and biomarker outcomes. Positive results from such a RCT would support lithium aspartate as a disease-modifying therapy for PD.

Being tested
Lithium aspartate
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lithium aspartateDietary supplement

    Also called Lithitate

    Lithium aspartate 30-45mg/day

Study groups in NCT06099886
Study groupRoleWhat they receive
Lithium aspartateExperimentalLithium aspartate capsules will be titrated in each patient to the maximum tolerated dosage between 30-45mg/day.
Receives: Dietary Supplement: Lithium aspartate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

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

    PBMC Nurr1 mRNA expression using Taqman PCR.

    Measured: Change from BL to 24 weeks.

Secondary outcomes (13)

  1. Serum Neurofilament Light (NfL)

    Assessed using SIMOA platform

    Measured: Change from BL to 24 weeks.

  2. Serum Glial Fibrillary Acidic Protein (GFAP)

    Assessed using SIMOA platform

    Measured: Change from BL to 24 weeks.

  3. PBMC Superoxide Dismutase Type-1 (SOD-1) mRNA Expression

    PBMC SOD-1 mRNA expression using Taqman PCR.

    Measured: Change from BL to 24 weeks.

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

    Assessed using ELISA

    Measured: Change from BL to 24 weeks.

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

    Assessed using ELISA

    Measured: Change from BL to 24 weeks.

  6. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)

    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.

    Measured: Change from BL to 24 weeks.

  7. Montreal Cognitive Assessment (MoCA)

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

    Measured: Change from BL to 24 weeks.

  8. Parkinson's Anxiety Scale

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

    Measured: Change from BL to 24 weeks.

  9. Geriatric Depression Scale-15

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

    Measured: Change from BL to 24 weeks.

  10. Fatigue Severity Scale

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

    Measured: Change from BL to 24 weeks.

  11. Insomnia Severity Index

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

    Measured: Change from BL to 24 weeks.

  12. Parkinson's Disease Questionnaire-8

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

    Measured: Change from BL to 24 weeks.

  13. Levodopa Equilavent Dose

    Higher scores indicate higher dose of dopaminergic therapy.

    Measured: Change from BL to 24 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start12 Oct 2023
  3. Primary completion6 Dec 2024
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099886
Sponsor's protocol ID
STUDY00007253
Other IDs
UL1TR001412
Status last verified
Apr 2026
First submitted
30 Aug 2023
Last updated
13 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will be considered on a case-by-case basis.

Publications

  • 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.

    PubMed 37215748

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lithium aspartate in people with Parkinson's Disease, run by State University of New York at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI-derived Free Water (FW) Levels (time frame: Change from baseline (BL) to 24 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06099886, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in