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

Inclusion Criteria

• •Patients aged 30-90 years, both genders
• •Patients or care-giver must provide informed consent and be willing and able to comply with study procedures.
• •Patients must be diagnosed with Parkinson's disease defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities.
• •Patients must have dementia as defined by (1) decline in cognitive function and (2) functional impairment, which together in, in the opinion of the investigator, has resulted in a clinical diagnosis of dementia.
• •MoCA \< 24 in support of a dementia diagnosis
• •Have a reliable and actively involved caregiver who must be able to communicate in English and be willing to comply with protocol requirements.
• •If on anti-parkinsonian agents, participants must be on stable dosage for at least 4 weeks prior to baseline.
• •If on medications enhancing cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 8 weeks prior to baseline.
• •If on antidepressant medications, participants must be on stable dosage for at least 4 weeks prior to baseline.
• •If on clozapine, pimavanserin or quetiapine to address drug-induced or disease-related psychosis, participants must be on stable dosage for 4 weeks prior to baseline.
• •Female patients of childbearing potential must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. A vasectomized partner will be allowed as one in conjunction with another single-barrier method.
• •Female patients unable to bear children must have this documented in the case report form (CRF) (i.e., tubal ligation, hysterectomy, or postmenopausal \[defined as a minimum of one year since the last menstrual period\]). Post-menopausal status will be confirmed by follicle stimulating hormone (FSH) in women less than 60 years of age.