NCT06887192

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: MapLight Therapeutics · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Psychosis Associated With Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ML-007C-MA	ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID
DRUG	Placebo	Placebo Tablets

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-20
• Last updated: 2026-03-09

Locations

26 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study