Long-term ML-007C-MA treatment for adults with Alzheimer's disease psychosis
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
This 52-week open-label extension will test ML-007C-MA to see if it is safe, tolerable, and helpful for adults with psychosis related to Alzheimer's disease who completed the earlier ML-007C-MA study.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 55 Years to 91 Years |
| Sex | All |
| Sponsor | MapLight Therapeutics Industry-sponsored |
| Locations | 3 sites (Doral, Florida and 2 other locations) |
| Trial ID | NCT07459660 on ClinicalTrials.gov |
What this trial studies
This open-label, flexible-dose 52-week extension enrolls adults with psychosis associated with Alzheimer's disease who completed the antecedent ML-007C-MA-221 double-blind period. Participants will receive ML-007C-MA and be followed for long-term safety, tolerability, and clinical effectiveness measures. A designated care partner is required to report symptoms and adherence, and participants must remain in a stable living situation for the study duration. The study excludes individuals receiving end-of-life or hospice care.
Who should consider this trial
Good fit: Adults with psychosis related to Alzheimer's disease who completed the antecedent ML-007C-MA-221 double-blind period, have a reliable care partner, and live in a stable residence are ideal candidates.
Not a fit: People who are bed-bound, under hospice or end-of-life palliative care, or who did not participate in the antecedent ML-007C-MA-221 study are unlikely to benefit from this extension.
Why it matters
Potential benefit: If successful, this could provide evidence that ML-007C-MA is a tolerable long-term option to reduce psychosis symptoms in people with Alzheimer's disease.
How similar studies have performed: Open-label extension studies have commonly been used to gather long-term safety data for treatments in Alzheimer's psychosis, although long-term effectiveness data for many agents remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Doral, Florida and 2 other locations
- Clinical Site — Doral, Florida, United States (Recruiting)
- Clinical Site — Miami, Florida, United States (Recruiting)
- Clinical Site — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Contact Center
- Email: ML-007C-MA-ADP@maplightrx.com
- Phone: +1 650 839 4380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.