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

Recruiting at 16 trial locations

Overseen By Clinical Trials Contact Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MapLight Therapeutics

Disqualifiers: Hospice care, Substance abuse, CNS disorder, Depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ML-007C-MA, an experimental therapy, to determine its effectiveness in reducing hallucinations and delusions in individuals with Alzheimer's Disease Psychosis. Participants will receive either the treatment or a placebo, a harmless pill with no active medicine, to compare results. The trial aims to assess the treatment's safety and effectiveness. It seeks individuals who have experienced hallucinations and delusions due to Alzheimer's for at least two months and have a care partner to help report symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that ML-007C-MA might be a safe treatment for people with Alzheimer's Disease Psychosis. In earlier studies, most patients tolerated ML-007C-MA well, experiencing no severe side effects. The treatment also demonstrated good results in drug delivery to the brain, which is crucial for its effectiveness. Although this treatment is still under testing, its trial in humans indicates it has passed initial safety checks. ^{1 2 3 4 5}

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

Unlike the standard of care for Alzheimer's disease psychosis, which often involves antipsychotics like risperidone or olanzapine, ML-007C-MA acts on a different pathway. Researchers are excited because ML-007C-MA targets specific receptors in the brain associated with neuropsychiatric symptoms, potentially reducing side effects commonly seen with current treatments. By focusing on this novel mechanism, ML-007C-MA offers hope for more effective and safer management of psychotic symptoms in Alzheimer's patients.

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

Research has shown that ML-007C-MA, which participants in this trial may receive, targets specific brain areas associated with psychosis symptoms. In animal studies, ML-007 proved ten times more effective than xanomeline, a similar drug, at reducing signs of psychosis. Although it appeared less potent in lab tests, its real-world effects in animals were impressive. This suggests ML-007C-MA could help manage hallucinations and delusions in individuals with Alzheimer's Disease Psychosis (ADP). The drug is also expected to be easy to take and well-tolerated, making it a promising option for those facing these challenging symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

MapLight Therapeutics

Principal Investigator

MapLight Therapeutics

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ML-007C-MA or placebo for the treatment of hallucinations and delusions associated with Alzheimer's Disease Psychosis

7 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 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Recent advancements in understanding psychosis in Alzheimer's disease have led to new diagnostic criteria and treatment approaches, emphasizing the importance of early symptom assessment even before dementia develops.

Pimavanserin shows promise as a novel treatment for psychosis in dementia, while existing medications like escitalopram and cholinesterase inhibitors may also be beneficial but require further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosis in Alzheimer disease - mechanisms, genetics and therapeutic opportunities. Ismail, Z., Creese, B., Aarsland, D., et al.[2023]

In a 10-week study involving 256 institutionalized Alzheimer's patients, aripiprazole did not show significant improvement in primary psychotic symptoms compared to placebo, indicating it may not be effective for this specific use.

However, aripiprazole did lead to improvements in secondary symptoms like agitation, anxiety, and depression, with a low incidence of adverse effects, particularly mild somnolence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study of aripiprazole for the treatment of psychosis in nursing home patients with Alzheimer disease. Streim, JE., Porsteinsson, AP., Breder, CD., et al.[2022]

Vitamin D usage was more common among Alzheimer's disease patients without psychosis symptoms, and it was linked to a delay in the onset of psychosis, suggesting a potential preventive role.

The study identified that vitamin D affects genes related to calcium signaling, which may help in developing new treatments for psychosis in Alzheimer's patients, and genetic variations in these genes could help identify patients who might benefit from vitamin D therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Vitamin D Use on Outcomes of Psychotic Symptoms in Alzheimer Disease Patients. Wang, L., Ying, J., Fan, P., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06887192

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 for the treatment of hallucinations and delusions associated with ADP as ...

2. maplightrx.com maplightrx.com/maplight-therapeutics-announces-ml-007c-ma-phase-2-initiation-alzheimers-disease-psychosis/

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 ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-the-efficacy-and-safety-of-ml-007c-ma-for-the-treatment-of-alzheimers-disease-psy

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 associated with ADP as ...

4. nature.com nature.com/articles/s41386-025-02256-3

Preclinical efficacy of the muscarinic agonist ML-007 in ... While ML-007 is less potent than xanomeline at M1 and M4 receptors in vitro, ML-007 is ten-fold more potent in animal models of psychosis. We ...

5. prnewswire.com prnewswire.com/news-releases/maplight-therapeutics-announces-initiation-of-phase-2-trial-of-novel-m1m4-muscarinic-agonist-ml-007c-ma-for-the-treatment-of-alzheimers-disease-psychosis-302559110.html

MapLight Therapeutics Announces Initiation of Phase 2 ... MapLight Therapeutics Announces Initiation of Phase 2 Trial of Novel M1/M4 Muscarinic Agonist ML-007C-MA for the Treatment of Alzheimer's ...

6. withpower.com withpower.com/trial/phase-2-alzheimer-disease-2-2025-048f4

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