Actively Recruiting
An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adults With Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
Led by MapLight Therapeutics · Updated on 2026-04-14
210
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the long-term use of ML-007C-MA in adults aged 55 to 91 who have hallucinations and delusions related to Alzheimer's Disease Psychosis (ADP). It is an open-label extension study following participants who completed a previous study with the same drug. The main goal is to evaluate the safety, tolerability, and effectiveness of ML-007C-MA over a one-year period. Participants receive flexible doses of ML-007C-MA, either 105/1.5 mg twice daily or 210/3 mg twice daily. The study lasts up to 52 weeks and allows dose adjustments as needed. This extension study builds on treatment from an earlier double-blind study, focusing on long-term outcomes. During the study, participants will be closely monitored for safety and tolerability through regular assessments. A designated care partner will help report symptoms and medication adherence. Researchers will observe any changes in hallucinations and delusions and track any side effects throughout the year. The study is conducted in stable living environments to maintain consistent monitoring and care.
CONDITIONS
Brief Title
An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent, or if lacking capacity, has a legally authorized representative provide consent and the participant provides assent
- Completed the double-blind treatment period of a previous ML-007C-MA study (ML-007C-MA-221)
- May benefit from long-term therapy with ML-007C-MA, as judged by the investigator
- Has a designated study care partner in frequent contact to report symptoms and medication adherence
- Resides in a stable living environment and is expected to remain there throughout the study
You will not qualify if you...
- Under hospice care, bed-bound, or receiving end-of-life palliative care
- Requires treatment with prohibited medications as defined by the study protocol
- Developed a new or worsening medical condition during or since the previous study that compromises safety or compliance
- Has clinically significant abnormal exams, vital signs, ECG, or lab results since the previous study that affect safety or study assessments
- Developed allergy or intolerance to ML-007C-MA or its ingredients since the previous study
- Has an elevated risk of suicidal behavior
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive ML-007C-MA to assess the long-term safety and tolerability for hallucinations and delusions associated with Alzheimer's Disease psychosis.
Trial Site Locations
Total: 3 locations
1
Clinical Site
Doral, Florida, United States, 33122
Actively Recruiting
2
Clinical Site
Miami, Florida, United States, 33155
Actively Recruiting
3
Clinical Site
Miami, Florida, United States, 33173
Actively Recruiting
Research Team
C
Clinical Trials Contact Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here