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Parkinson DiseasePhase 1/2NCT06592014

Lithium for Parkinson's: an Extension Trial

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

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Lithium aspartate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
9 Aug 2024to 1 Nov 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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. All PD patients completing STUDY00007253 or STUDY00008239 at the University at Buffalo will be eligible.
  2. No unstable cardiac, medical, neurologic or psychiatric condition in the opinion of the PI.
  3. No current use of illicit drugs or current alcohol abuse in the opinion of the PI.
  4. No history of brain surgery or possible need for brain surgery including deep brain stimulation (DBS) for at least 24 weeks in the opinion of the PI.
  5. Women with child bearing potential will need a negative pregnancy test and not be nursing an infant at screening. Women with child bearing potential will need to report using barrier method or hormonal contraception.
  6. Willing and able to sign informed consent and follow study procedures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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: an Open-label Extension Trial.

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.

Read the detailed description

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.

Being tested
Lithium aspartate
Keywords
lithium, biomarker, free water, neurofilament light chain
Medical subject headings
Parkinson Disease, Charcot-Marie-Tooth disease, Type 1F

What participants receive

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

  • Lithium aspartateDietary supplement

    Lithium aspartate with dosage adjusted to serum lithium level 0.25-0.50mmol/L

Study groups in NCT06592014
Study groupRoleWhat they receive
Lithium aspartateExperimentalLithium aspartate with dosage adjusted to achieve a serum lithium level of 0.25-0.50mmol/L
Receives: Dietary Supplement: Lithium aspartate

What is being measured

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

  1. Free Water

    Change in MRI-assessed free water in posterior substantia nigra, dorsomedial nucleus of the thalamus and nucleus basalts of Meynert.

    Measured: 24 Weeks.

  2. Serum neurofilament light chain

    Change in serum neurofilament light chain

    Measured: 24 weeks

Secondary outcomes (11)

  1. Peripheral blood mononuclear cell (PBMC) Nurr1 mRNA levels by real-time polymerase chain reaction (PCR)

    Change in PBMC Nurr1

    Measured: 24 weeks

  2. PBMC superoxide dismutase 1 (SOD-1) mRNA levels

    Change in PBMC SOD-1

    Measured: 24 weeks

  3. 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

    Measured: 24 weeks

  4. PBMC pThr308, pS473 and t-protein kinase B (Akt)

    Change in pThr308, pS473 and t-Akt

    Measured: 24 weeks

  5. 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.

    Measured: 24 weeks

  6. Parkinson's Anxiety Scale

    Change in Parkinson's Anxiety Scale scores, Score range 0-48 with higher scores indicating worse outcomes.

    Measured: 24 weeks

  7. Geriatric Depression Scale-15

    Change in Geriatric Depression Scale-15 scores, Score range 0-15 with higher scores indicating worse outcomes.

    Measured: 24 weeks

  8. Fatigue Severity Scale

    Change in Fatigue Severity Scale scores, Score range 9-63 with higher scores indicating worse outcomes.

    Measured: 24 weeks

  9. Insomnia Severity Index

    Change in Insomnia Severity Index, Score range 0-28 with higher scores indicating worse outcomes.

    Measured: 24 weeks

  10. Parkinson's Disease Questionnaire-8

    Change in Parkinson's Disease Questionnaire-8 scores, Score range 0-32 with higher scores indicating worse outcomes.

    Measured: 24 weeks

  11. 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.

    Measured: 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 posted19 Sep 2024
  2. Study start9 Aug 2024
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Nov 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06592014
Sponsor's protocol ID
STUDY00008239
Status last verified
Oct 2026
First submitted
8 Sep 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patient demographics and outcome measure results.

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 aspartate 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?

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: enrolling by invitation, 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. 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?

Free Water (time frame: 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 NCT06592014, 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; AzTrials last refreshed its copy on 26 Oct 2026.

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