NCT07459660 An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
| NCT ID | NCT07459660 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | MapLight Therapeutics |
| Condition | Psychosis Associated With Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 210 participants in total. It began in 2026-03-25 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria 1. Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met: 1. The participant's LAR must provide written informed consent. AND 2. The participant will provide informed assent. 2. Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221). 3. May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator. 4. Has a designated study care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug. 5. Resides in a stable living environment (eg, home, residential assisted living, or nursing home facility) and is expected to remain in the living situation throughout the study. Exclusion Criteria 1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care. 2. Requires treatment with protocol-defined prohibited medications. 3. Has developed a new or worsening medical comorbidity during or since the antecedent study that, in the opinion of the investigator and/or medical monitor, would compromise participant safety, interfere with the participant's ability to comply with study procedures, would preclude obtaining voluntary consent/assent, and/or would substantially impair the evaluation of study assessments. 4. Has or had a clinically significant abnormal physical examination, vital sign, ECG or clinical laboratory safety result during or since the antecedent study that would compromise participant safety, interfere with the participant's ability to comply with study procedures, and/or would confound the interpretation of the outcome measures in the study in the opinion of the investigator. 5. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study. 6. Has an elevated risk of suicidal behavior.
Contact & Investigator
MapLight Therapeutics
STUDY DIRECTOR
MapLight Therapeutics
Frequently Asked Questions
Who can join the NCT07459660 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 91 Years, studying Psychosis Associated With Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07459660 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07459660 currently recruiting?
Yes, NCT07459660 is actively recruiting participants. Contact the research team at ML-007C-MA-ADP@maplightrx.com for enrollment information.
Where is the NCT07459660 trial being conducted?
This trial is being conducted at Doral, United States, Miami, United States, Miami, United States.
Who is sponsoring the NCT07459660 clinical trial?
NCT07459660 is sponsored by MapLight Therapeutics. The principal investigator is MapLight Therapeutics at MapLight Therapeutics. The trial plans to enroll 210 participants.
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