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

Enrolling by invitation at 6 trial locations
CT
Overseen ByClinical Trials Contact Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: MapLight Therapeutics
Must be taking: ML-007C-MA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the long-term safety and effectiveness of ML-007C-MA, an experimental treatment for Alzheimer's Disease Psychosis (ADP). It focuses on individuals who have completed a previous study with this treatment and might benefit from continued therapy. Ideal participants live in stable environments, such as at home or in assisted living, and have a care partner to assist with study requirements. The trial excludes anyone currently in hospice care or who has developed new health issues that could affect participation. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain medications are prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that ML-007C-MA is likely to be safe for humans?

Research shows that ML-007C-MA might be safe for people with Alzheimer's disease psychosis. In studies, some patients tolerated this treatment well. Reports from these studies have not identified any major safety issues, indicating that serious side effects were uncommon. However, individual experiences can vary with any new treatment. Researchers are carefully studying this new drug to ensure its safety and effectiveness for patients. So far, the results appear promising for its safety.12345

Why do researchers think this study treatment might be promising for Alzheimer's Disease Psychosis?

Unlike the standard treatments for Alzheimer's disease psychosis, which often include antipsychotics like risperidone or olanzapine, ML-007C-MA offers a novel approach. This experimental treatment targets specific pathways in the brain associated with psychosis, potentially reducing symptoms without the severe side effects that are common with current medications. Researchers are particularly excited about ML-007C-MA because it may improve patient quality of life by providing relief from psychotic symptoms faster and with fewer adverse effects.

What evidence suggests that ML-007C-MA might be an effective treatment for Alzheimer's Disease Psychosis?

Research has shown that ML-007C-MA, the investigational treatment in this trial, helps alleviate hallucinations and delusions in people with Alzheimer's disease. It targets specific brain receptors to reduce these symptoms. Animal studies found ML-007C-MA to be more potent than some other treatments for psychosis. Earlier studies in humans suggested that most participants tolerated ML-007C-MA well. These findings indicate that ML-007C-MA could be a safe and effective treatment for Alzheimer's disease psychosis.23467

Who Is on the Research Team?

MT

MapLight Therapeutics

Principal Investigator

MapLight Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with Alzheimer's disease psychosis who finished a previous related study, have a reliable care partner, and live in a stable environment. People can't join if they are at high risk of suicide, have allergies to the drug, need certain restricted medications, or have serious new health issues.

Inclusion Criteria

I am willing and able to give written consent to join the study.
Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA
My condition may improve with long-term ML-007C-MA treatment.
See 2 more

Exclusion Criteria

Has an elevated risk of suicidal behavior
Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients, or their excipients
Requires treatment with protocol-defined prohibited medications
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive ML007C-MA to evaluate long-term safety, tolerability, and effectiveness

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ML-007C-MA

Trial Overview

The study tests the long-term safety and effectiveness of ML-007C-MA for up to one year in people with Alzheimer's disease psychosis. All participants receive the medication; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ML-007C-MAExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MapLight Therapeutics

Lead Sponsor

Trials
3
Recruited
570+

Citations

Fast Track Designation Granted: ML-007C-MA for ...

ML-007C-MA targets hallucinations and delusions in Alzheimer's disease psychosis, activating M1/M4 muscarinic receptors while minimizing ...

A Study to Assess the Efficacy and Safety of ML-007C-MA ...

The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of ...

A Study to Assess the Efficacy and Safety of ML-007C-MA for ...

The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions ...

A Study to Assess the Efficacy and Safety of ML-007C-MA for ...

The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions ...

MapLight Therapeutics Announces Initiation of Phase 2 ...

ML-007C-MA offers the potential to be a well-tolerated treatment option with convenient dosing, while achieving or exceeding CSF exposures ...

NCT07459660 | An Open-Label Study of ML-007C-MA in ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis.

FDA Grants Fast Track Designation to ML-007C-MA for ...

New investigational drug ML-007C-MA receives FDA Fast Track status for the development of treatment for Alzheimer-related delusions.