Phase 2RecruitingAge-related condition
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
- Sponsor
- MapLight Therapeutics (Industry)
- Enrollment
- 300 planned
- Conditions
- Psychosis Associated With Alzheimer's Disease
- Interventions
- ML-007C-MA; Placebo
- Ages
- adults, older adults
- Registry
- NCT06887192, CTIS2024-519820-26-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
History
Primary completion expected
Last registry update
Started
Registered