RecruitingPhase 2NCT06887192

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

Enrollment

300 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ML-007C-MA for treating psychosis in people with Alzheimer's disease. Psychosis in Alzheimer's means experiencing hallucinations or delusions — seeing, hearing, or believing things that aren't real. This is a significant source of distress for patients and caregivers. **You may be eligible if...** - You or your loved one has a clinical diagnosis of possible or probable Alzheimer's disease - There are symptoms of psychosis (like hallucinations or delusions) present - A legal representative can provide consent if the participant cannot do so themselves **You may NOT be eligible if...** - There are certain serious medical conditions or medications that conflict with the study drug - The psychosis symptoms are caused by another condition - You are not stable enough medically to participate safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGML-007C-MA

ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID

DRUGPlacebo

Placebo Tablets


Locations(26)

Clinical Site

Phoenix, Arizona, United States

Clinical Site

Scottsdale, Arizona, United States

Clinical Site

Tucson, Arizona, United States

Clinical Site

Anaheim, California, United States

Clinical Site

Orange, California, United States

Clinical Site

San Diego, California, United States

Clinical Site

Boca Raton, Florida, United States

Clinical Site

Deerfield Beach, Florida, United States

Clinical Site

Doral, Florida, United States

Clinical Site

Homestead, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami Gardens, Florida, United States

Clinical Site

Miami Gardens, Florida, United States

Clinical Site

Naples, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site

West Palm Beach, Florida, United States

Clinical Site

Las Vegas, Nevada, United States

Clinical Site

West Long Branch, New Jersey, United States

Clinical Site

Independence, Ohio, United States

Clinical Site

Brampton, Ontario, Canada

Clinical Site

London, Ontario, Canada

Clinical Site

Toronto, Ontario, Canada

Clinical Site

Lévis, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06887192


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