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Parkinson DiseasePhase 1/2NCT06339034

Repurposing Lithium for Parkinson's Disease: a RCT

A Phase 1/2 study testing Lithium in people with Parkinson Disease, run by State University of New York at Buffalo at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 early-stage Parkinson's disease patients. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Lithium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
3 Jul 2024to Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 40 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

  • UBMD Neurology

    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 Randomized Controlled Trial

This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 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 therapy in PD to improve both MRI and blood-based biomarkers implying that lithium may be slowing the progression of the disease. However, these findings stem from only three of four patients receiving MRIs. A larger study will be required to determine if these promising results can be replicated. The proposed study will enroll 20 additional PD patients who will be randomly assigned to receive either lithium 20mg/day or identically-appearing placebo capsules for 24 weeks. This will be a double-blind study meaning that neither the patients nor the study team will know to which therapy patients have been assigned. Positive results from this study will support further research on lithium that could eventually support lithium as a disease-modifying therapy for PD that could improve patients' long-term prognoses.

Being tested
Lithium, Placebo
Keywords
Parkinson's, Lithium, Free water, Disease-modifying therapy
Medical subject headings
Parkinson Disease

What participants receive

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

  • LithiumDietary supplement

    5mg of elemental lithium/capsule

  • PlaceboOther

    Cellulose-filled capsules

Study groups in NCT06339034
Study groupRoleWhat they receive
LithiumActive comparatorLithium: 10mg, 2x/day
Receives: Dietary Supplement: Lithium
PlaceboPlacebo comparatorIdentical capsules filled with cellulose: 10mg, 2x/day
Receives: Other: Placebo

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 week

  2. Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression

    PBMC Nurr1 mRNA expression using Taqman PCR.

    Measured: Change from baseline (BL) to 24 week

  3. Serum neurofilament light chain (NfL)

    Serum NfL assessed using SIMOA platform by Quanterix (Lexington, MA)

    Measured: Change from baseline (BL) to 24 week

Secondary outcomes (13)

  1. PBMC superoxide dismutase type-1 (SOD-1) mRNA expression

    PBMC SOD-1 mRNA expression using Taqman PCR

    Measured: Change from baseline (BL) to 24 week

  2. PBMC pS9/total glycogen synthase kinase-3B (GSK-3B) ratio

    Assessed using ELISA

    Measured: Change from baseline (BL) to 24 week

  3. PBMC pThr308 and pS473/total protein kinase B (Akt) ratios

    Assessed using ELISA

    Measured: Change from baseline (BL) to 24 week

  4. Serum interleukin-6

    Assessed using ELISA

    Measured: Change from baseline (BL) to 24 week

  5. Serum glial fibrillary acidic protein (GFAP)

    Serum GFAP assessed using SIMOA platform by Quanterix (Lexington, MA)

    Measured: Change from baseline (BL) to 24 week

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

    Assessed in the "on" state. Score range 0-132 with higher scores indicating worse outcomes.

    Measured: Change from baseline (BL) to 24 week

  7. Montreal Cognitive Assessment (MoCA)

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

    Measured: Change from baseline (BL) to 24 week

  8. Parkinson's Anxiety Scale

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

    Measured: Change from baseline (BL) to 24 week

  9. Geriatric Depression Scale-15

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

    Measured: Change from baseline (BL) to 24 week

  10. Fatigue Severity Scale

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

    Measured: Change from baseline (BL) to 24 week

  11. Insomnia Severity Index

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

    Measured: Change from baseline (BL) to 24 week

  12. Parkinson's Disease Questionnaire-8

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

    Measured: Change from baseline (BL) to 24 week

  13. Levodopa equivalent daily dose (LEDD)

    Higher scores indicate higher dose of dopaminergic therapy.

    Measured: Change from baseline (BL) to 24 week

Timeline

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

  1. First posted1 Apr 2024
  2. Study start3 Jul 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind, placebo-controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06339034
Sponsor's protocol ID
STUDY
Status last verified
Oct 2026
First submitted
24 Mar 2024
Last updated
26 Oct 2026
Results posted
No
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 1/2 study testing Lithium in people with Parkinson 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 week). The study lists 3 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 NCT06339034, 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 26 Oct 2026.

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Repurposing Lithium for Parkinson's Disease: a RCT | AzTrials