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

Recruiting at 1 trial location

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

Trial Summary

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.

What data supports the effectiveness of the drug ML-007C-MA for treating psychosis in Alzheimer's disease?

The research highlights that new drug approaches, like pimavanserin, show promise for treating psychosis in dementia, and existing drugs such as escitalopram and vitamin D might be useful but need more exploration. This suggests that similar treatments to ML-007C-MA could potentially be effective for Alzheimer's-related psychosis. ^{1 2 3 4 5}

What makes the drug ML-007C-MA unique for treating Alzheimer's disease psychosis?

The research does not provide specific information about ML-007C-MA, but it highlights the need for new treatments for Alzheimer's disease psychosis, as current options are limited and often lack safety and effectiveness. Novel approaches, like pimavanserin, are being explored, suggesting that ML-007C-MA might offer a new mechanism or improved safety profile. ^{1 3 6 7 8}

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

Timeline

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

Treatment Details

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.

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Psychosis in Alzheimer disease - mechanisms, genetics and therapeutic opportunities. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Psychosis of Alzheimer's disease: clinical characteristics and history. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Psychosis in Alzheimer's Disease. [2021]

4. England 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of Vitamin D Use on Outcomes of Psychotic Symptoms in Alzheimer Disease Patients. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Reduced parahippocampal volume and psychosis symptoms in Alzheimer's disease. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Right hippocampus atrophy is independently associated with Alzheimer's disease with psychosis. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Reduced Thickness of the Anterior Cingulate Cortex as a Predictor of Amnestic-Mild Cognitive Impairment Conversion to Alzheimer's Disease with Psychosis. [2022]