An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

Condition studied

Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

Eligibility

Primary endpoint

Incidence of TEAEs, treatment-emergent SAEs, and TEAEs leading to study discontinuation

Endpoint detail

Safety: • Observed values and changes from OL Baseline in clinical safety laboratory assessments, 12-lead ECG parameters, vital sign parameters, and body weight • GCAS score • Changes from OL Baseline in ESRS-A score • Changes from OL Baseline in MMSE score, Effectiveness: Changes from OL Baseline in the following: • NPI-C H+D score • CGI-S hallucinations and delusions domain-specific score • NPI-C A+A score in participants who had a CGI-S agitation and aggression domain-specific score of ≥4 at OL Baseline • ADCS-ADL total score, Effectiveness: Changes from OL Baseline in ZBI-12 score, Pharmacokinetic: Plasma concentrations of ML-007 (and its major metabolites, if applicable)