Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug

Exclusion Criteria

• •Patients who meet any of the following conditions are excluded from the clinical study:
• •Inability of subject or caretaker to provide informed consent.
• •Pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative urine pregnancy test at screening.
• •Female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception during the study and for at least one month prior to randomization and one month following completion of the study.
• •Presence of any systemic factor contributing to the psychosis such as urinary infection, liver disease, renal failure, anemia, infection, etc. as defined by a comprehensive medical evaluation.
• •History of a significant pre-morbid psychiatric condition before the diagnosis of Parkinson's disease, including major depression, mania, or psychotic depression.
• •Dementia precluding accurate assessment on psychiatric assessment battery and defined as a score on the MMSE \< 21.
• •Use of depot neuroleptic within the past year.
• •Prior exposure to non-depot neuroleptics within the past 90 days, except for quetiapine or clozapine. Quetiapine and clozapine-treated patients may be enrolled if these agents were discontinued due to drug intolerability. Such patients must not have taken these drugs within the past two weeks.
• •Use of the following drugs within the past two weeks: benztropine, biperiden, trihexylphenidyl, amitriptyline, clomipramine, desipramine, nortriptyline, imipramine, doxepin, fluvoxamine, mirtazepine, nefazodone and trazodone.
• •Change of anti-depressant, anxiolytic, anticholinergic (specifically oxybutynin, tolterodine), or cognitive enhancer (specifically rivastigmine, tacrine, donepezil, galantamine) dose within the past 30 days and during the 28-day duration of the trial.
• •Use of any investigational product within the past 30 days.
• •Inability to tolerate a stable level of anti-parkinsonian medications for one week.
• •Uncontrolled angina or history of a myocardial infarction within the past three months.
• •Concurrent illness that would make use of ACP-103 potentially hazardous.