Evaluating ML-007C-MA for Treating Hallucinations and Delusions in Adults Aged 55 to 90 with Alzheimers Disease Psychosis

What this Trial Is About

Researchers are studying ML-007C-MA to assess its safety and effectiveness in treating hallucinations and delusions in adults aged 55 to 90 who have Alzheimers Disease Psychosis ADP. This phase 2 randomized, double-blind, placebo-controlled trial aims to compare ML-007C-MA with a placebo by measuring changes in specific symptoms using the Neuropsychiatric Inventory-Clinician NPI-C Hallucinations and Delusions score. Participants will be randomly assigned to receive either ML-007C-MA at doses of 1051.5 mg or 2103 mg twice daily, or placebo tablets. The treatment period lasts 7 weeks, during which the study will monitor symptom changes and safety. The study includes adults with confirmed ADP and psychotic symptoms who have a designated care partner to help with symptom reporting and medication adherence. Throughout the trial, participants will undergo assessments including the NPI-C Hallucinations and Delusions score, Clinical Global Impressions-Severity CGI-S scale, and Mini-mental State Examination MMSE. These evaluations occur at the start and end of the 7-week treatment to measure symptom changes. Safety monitoring and adherence tracking will be part of the study, which is scheduled to complete by December 2027.

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis