Safety and Biomarker Study of EPI-589 in Parkinson's Disease

This is a within-subject, controlled open-label study seeking to determine if EPI-589 can
alter the biochemical signature of PD as assessed by peripheral blood and brain imaging
biomarkers. Data will also be collected on disease-relevant clinical measures will be
collected.

Inclusion Criteria:

- Hoehn and Yahr stage ≤ 3.0

- Ambulatory with or without assistance

- Sexually active fertile subjects and their partners must agree to use medically
accepted methods of contraception (e.g., hormonal methods, including oral,
subcutaneous, and intrauterine; barrier methods, including male condom, female condom,
or diaphragm with spermicidal gel) during the course of the study and for 3 months
after the last dose of study treatment.

- Willingness and ability to comply with study procedures

- If on medications for PD drugs, then medication regimen must be stable for 60 days
prior to enrollment

- Abstention from use of other investigative or nonapproved drugs for the duration of
the trial.

For Idiopathic Subjects

- A diagnosis of idiopathic PD confirmed by the presence of bradykinesia plus one or
both of the following symptoms: rigidity or resting tremor; and with an abnormal
DaTscan consistent with a dopaminergic deficit

- Age 40 to 75 years

- Within 5 years of diagnosis of Parkinson's disease

For Genetic Subtype Subjects

- A confirmed diagnosis of PD plus a genetic diagnosis consistent with PD, specifically
PINK1, parkin, LRRK2 or other mitochondrial genetic subtype

- Age 21 to 75 years

Exclusion Criteria:

- Allergy to EPI-589 or other components of the EPI-589 tablet formulation

- Use of antioxidant supplements, specifically vitamins E and C beyond the recommended
daily allowance

- Other Parkinsonian disorders

- MoCA score of <24

- Revised Hamilton Rating Scale for Depression ≥ 11

- Parkinsonism due to drugs or toxins

- Diagnosis of any other clinically significant neurologic disease that will confound
the assessment of effect of study drug on disease progression

- Malignancy within past two years

- Pregnant or plans to become pregnant or breast feeding

- History of stroke

- History of brain surgery

- Hepatic insufficiency with liver function tests (LFTs) >3 times upper limit of normal

- Renal insufficiency as defined by creatinine > 1.5 times normal

- End stage cardiac failure

- Participation within past 3 months and for duration of study in a trial of a device,
drug or other therapy for PD