Study Enrollment

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Clinical Trial

Study to evaluate the safety, tolerability, and efficacy of ganglioside administration for neurodegenerative diseases

This study proposes to develop a novel treatment for Parkinson?s disease (PD) using gangliosides. Our team found that gangliosides can prevent the accumulation of a toxic protein to keep dopaminergic neurons functioning properly. We also want to examine that those gangliosides can regenerate the dopamine-producing cells within the brain. Our long-term goal is to develop the ganglioside therapy as an effective disease-modifying treatment for PD and other similar brain diseases.

Eligibility Criteria

  • We will treat PD patients with intranasal GM1 ganglioside. PD subjects will be adult men and women (45-80 years old) diagnosed with idiopathic mild to moderately severe PD defined as modified Hoehn and Yahr Stages I-III (while during the stage of ?On? when their levodopa is alleviating their PD symptoms). The subject must have expected stability of PD medications for at least a month to be enrolled in the Phase1b study and a year for the Phase 2a study. Subjects will be excluded if they had previous brain surgery or other severe neurological problems - intracerebral hemorrhage, traumatic brain injury, recent malignancy other than treated basal cell/squamous cell skin cancer, active CNS infection, significant stroke, dementia or any type of implanted stimulator; including but not limited to Deep Brain Stimulator (DBS). Additionally, those with significant sinus disease, uncontrolled mental health issues, a history on medication non-compliance will be excluded.

Contact Information

    Yutaka Itokazu

    (706) 721-7089