A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP). The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
• Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:
‣ The participant's LAR (or care partner, if local regulations allow) must provide written informed consent AND
⁃ The participant will provide written (if capable) informed assent.
• Aged 55 to 90 years, inclusive, at time of informed consent.
• Meets clinical criteria for Possible AD or Probable AD.
• Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
• Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
• Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
• Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:
‣ Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR
⁃ Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.
• Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
• Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.