drugset / Trial / NCT06887192
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |