drugset / Trial / NCT06887192

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

NCT06887192 ↗

Phase 2 Recruiting 300 enrolled MapLight Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-08-15
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ML-007C-MA Unknown 1.5 mg —
Subject ML-007C-MA Unknown 3 mg —
Subject ML-007C-MA Unknown 105 mg —
Subject ML-007C-MA Unknown 210 mg —

Indications