An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML007C-MA in Adult Participants With Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
MapLight Therapeutics
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
- Age range
- 55–91 years
- Sex
- All
- Healthy volunteers
- No
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 contac…
Interventions
- DrugML-007C-MA
ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID
Locations (3)
- Clinical SiteDoral, Florida
- Clinical SiteMiami, Florida
- Clinical SiteMiami, Florida