Actively Recruiting
An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
Led by MapLight Therapeutics · Updated on 2026-04-14
210
Participants Needed
3
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
ML-007C-MA-222 is a 52-week, flexible-dose, open-label extension study designed to evaluate the long-term safety, tolerability, and effectiveness of ML007C-MA in participants with ADP who have completed the antecedent study (ie, Study ML-007C-MA-221).
CONDITIONS
Official 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 unable, have a legally authorized representative provide consent and participant provide assent
- Completed the double-blind treatment period of a previous ML-007C-MA study (ML-007C-MA-221)
- Judged by the investigator to potentially benefit from long-term open-label ML-007C-MA treatment
- Have a designated study care partner who frequently contacts the participant to report symptoms and medication adherence
- Reside in a stable living environment such as home, assisted living, or nursing home and expected to remain there during the study
You will not qualify if you...
- Currently under hospice care, bed-bound, or receiving end-of-life palliative care
- Require treatment with medications prohibited by the study protocol
- Developed a new or worsening medical condition since the previous study that compromises safety or ability to comply with study procedures
- Had clinically significant abnormal physical exam, vital signs, ECG, or lab safety results during or 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
- Have an elevated risk of suicidal behavior
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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