An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
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).
| Condition(s) | Psychosis Associated With Alzheimer's Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 nu |
| Ages | 55 Years to 91 Years |
| Sex | All |
| Lead sponsor | MapLight Therapeutics |
| Locations | Doral, Florida, United States; Miami, Florida, United States; Miami, Florida, United States |
| Start date | 2026-03-25 |
| NCT ID | NCT07459660 |
| Official listing | https://clinicaltrials.gov/study/NCT07459660 |