ML-007C-MA for Alzheimer's Disease Psychosis

Recruiting at 1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: MapLight Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

MapLight Therapeutics

Principal Investigator

MapLight Therapeutics

Eligibility Criteria

This trial is for men and women aged 55 to 90 with Alzheimer's Disease who are experiencing hallucinations and delusions. Participants must be diagnosed with Alzheimer's-related psychosis but the full eligibility criteria are not provided.

Inclusion Criteria

Willing and able to provide written informed consent

I have experienced symptoms like hallucinations or delusions for at least 2 months.

Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening

Exclusion Criteria

Inconsistent results from amyloid PET brain scan or CSF Alzheimer's disease biomarker test

Previous participation in specific clinical studies

Received or may have received investigational drugs within specified timeframes

Treatment Details

Interventions

• ML-007C-MA (Other)

Trial Overview The study tests ML-007C-MA against a placebo in treating hallucinations and delusions in Alzheimer's patients. It's a Phase 2 trial, meaning it focuses on efficacy and safety, where participants don't know if they're getting the real medicine or a dummy pill.

Participant Groups

Group I: ML-007C-MA Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

MapLight Therapeutics

Lead Sponsor

Trials

3

Recruited

570+