Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis

Eligibility Criteria

• 1. Use of anticonvulsant medications within 1 month prior to the baseline visit.
• 2. Participation in a therapeutic clinical study for any medical or psychiatric indications within 1 month of the screening visit, or at any time during the study. Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose/administration was received within 1 month prior to screening.
• 3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
• 4. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis.
• 5. Delirium due to the presence of an acute metabolic encephalopathy secondary to infection or from any other cause as assessed by the investigator based on labs, history, and physical exam.
• 6. Neurological disorder other than Parkinson's disease, such as Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities, that in the opinion of the investigator might interfere with the conduct of the study.
• 7. Prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder other than PD-related psychosis.
• 8. Stereotactic surgery for deep brain stimulation (DBS), presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body that constitute a contraindication to having an MRI scan.
• 9. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria).
• 10. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
• 11. Any unstable medical condition that is likely to require new medical or surgical treatment during the course of the study and where such treatments might affect the collection of efficacy data.
• 12. Unable or unwilling to provide informed consent or to comply with study procedures.
• 13. Patient or caregiver unable to administer daily oral dosing of study drug.
• 14. Current suicidal ideation.
• 15. Female subjects must not be pregnant or lactating.
• 16. Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.