OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001

Exclusion Criteria

• •History of any significant neurologic or psychiatric disorder other than PD that can contribute to cognitive impairment.
• •Any other condition or clinically significant abnormal findings on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the Investigator, would make the subject unsuitable for the study.
• •Potential symptomatic causes of cognitive impairment including but not limited to
• •abnormal thyroid function test at screening (TSH)
• •abnormal B12 level at screening
• •MRI findings (by history) pointing to a potential symptomatic cause of cognitive dysfunction, including significant vascular changes, or communicating hydrocephalus.
• •Treatment with memantine or amantadine. If appropriate the drugs can be discontinued for a minimum of 4 weeks prior to enrollment.
• •History of depression as measured by Beck Depression Inventory score \>17 at screening.
• •Treatment with any other investigational drug or device within 4 weeks prior to screening.
• •Smoking \> 1 pack of cigarettes per day (as assessed for the 4 weeks prior to screening).
• •Women who are pregnant or lactating.
• •Known allergy or sensitivity to ANAVEX2-73 or any of its components.
• •Suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or type 5, or any suicidal behavior, in the past 6 months. Type 4 indicates active suicidal ideation with some intent to act, without a specific plan. Type 5 indicates active suicidal ideation with a specific plan and intent.
• •Use of centrally acting anticholinergic drugs during the 4 weeks before enrollment.
• •Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to enrollment.
• •Treatment with any dopamine receptor blocking medications with the exception of low dose quetiapine (≤50 mg/day). Pimavanserin (≤34 mg/day) will be allowed.
• •History of neurosurgical intervention (e.g., deep brain stimulation) for PD.
• •Unpredictable motor fluctuations that would interfere with administering cognitive assessments in the ON state.