NCT06592014

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 parkinson-disease

Timeline
5mo left

Started Aug 2024

Typical duration for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Aug 2024Nov 2026

Study Start

First participant enrolled

August 9, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

September 8, 2024

Last Update Submit

November 18, 2025

Conditions

Parkinson Disease

Keywords

lithiumbiomarkerfree waterneurofilament light chain

Outcome Measures

Primary Outcomes (2)

  • Free Water

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

    24 Weeks.

  • Serum neurofilament light chain

    Change in serum neurofilament light chain

    24 weeks

Secondary Outcomes (11)

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

    24 weeks

  • PBMC superoxide dismutase 1 (SOD-1) mRNA levels

    24 weeks

  • PBMC phosphorylated (p) and total (t) levels of pS9 and total-glycogen synthase kinase 3B (GSK-3B)

    24 weeks

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

    24 weeks

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III

    24 weeks

  • +6 more secondary outcomes

Study Arms (1)

Lithium aspartate

EXPERIMENTAL

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

Dietary Supplement: Lithium aspartate

Interventions

Lithium aspartateDIETARY_SUPPLEMENT

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

Lithium aspartate

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UBMD Neurology

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: 37215748BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseCharcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Thomas Guttuso, MD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

September 8, 2024

First Posted

September 19, 2024

Study Start

August 9, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Patient demographics and outcome measure results.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
IPD will be made available after the study results are published.
Access Criteria
Researchers who have requested IPD from the PI.

Locations

US(1)