A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease Dementia

You may not qualify if:

• Patient or caregiver unable or unwilling to provide informed consent or to comply with study procedures.
• Unable to withdraw proton pump inhibitors at the end of run-in period.
• Unable to withdraw from anti-cholinergics at the beginning of the run-in period
• Any clinically significant abnormalities on screening laboratories or physical examination requiring further evaluation or treatment.
• Neurological disorder other than Parkinson's disease that in the opinion of the investigator might interfere with the conduct of the study
• Females who are pregnant or breastfeeding
• History of excessive alcohol use or substance abuse
• Psychotic disorder was present before the diagnosis of Parkinson's disease
• Patient or caregiver unable to administer daily oral dosing of study drug
• Caregiver unwilling or unable to unable to complete stool diary, dispense study medication and accompany the patient to all visits
• Participation in an investigational drug trial within the month prior to dosing in the present study.
• Review of Screening period diaries indicates either of the following: Fewer than 11 days of diary completion; More than 5 complete spontaneous bowel movements per week based upon the average Complete Spontaneous Bowel Movement (CSBM) rate reported during the Screening Period.
• Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.