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An Open-Label Study of ML-007C-MA in 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
Lead sponsor
Asset
ML-007C-MA
Listed sites
3
Recruiting sites
3
Enrollment
210
estimated
Study population
Alzheimer’s disease
Key I/E criterion
•Age 55-91
Primary endpoint
•Safety and tolerability of long-term ML-007C-MA administration
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (1)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
1 endpointTo assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD
Time frame:From initial dose through end of treatment (up to 52 weeks)
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.