Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis

Inclusion Criteria:

• Male or female ≥55 years to <85 years of age at the Screening visit living in thecommunity or, if permitted by local regulations, in an institutionalized setting

• Can provide written informed consent. If the subject is deemed not competent toprovide informed consent, the following requirements for consent must be met:

1. The subject's LAR must provide written informed consent.

2. The subject must provide written (if capable) informed assent per localregulations.

• Meets either the clinical criteria for Parkinson's disease with dementia as definedby the Movement Disorder Society's Task Force or the revised clinical criteria forprobable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensusreport of the DLB Consortium).

• Meets the revised criteria for psychosis in major or mild neurocognitive disorderestablished by the International Psychogeriatrics Association

Exclusion Criteria:

• Is in hospice, is receiving end-of-life palliative care, or is bedridden

• Has psychotic symptoms that are primarily attributable to delirium, substance abuse,or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder,delusional disorder) other than dementia

• Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)

• Has a history or current evidence of a serious and/or significant unstablecardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic,hematologic, immunologic, genitourinary, psychiatric or neurologic (includingstroke, chronic seizures, or clinically significant head injury) abnormality ordisease or other medical disorder, including cancer or malignancies that couldinterfere with subject's ability to complete the study or comply with studyprocedures

• Has other clinically significant CNS abnormalities that are most likely contributingto the dementia or findings on MRI or CT