A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease … (NCT06887192) | Clinical Trial Compass
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
United States, Argentina, Bulgaria300 participantsStarted 2025-08-15
Plain-language summary
ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP).
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Who can participate
Age range
55 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. The participant's LAR must provide written informed consent AND
. The participant will provide informed assent.
. Meets clinical criteria for Possible AD or Probable AD.
. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial, what do we know so far about the safety and effectiveness of ML-007C-MA, and how does being in an earlier-phase study affect the balance of potential risks and benefits for someone in my loved one's situation?
2The trial is specifically measuring changes in hallucinations and delusions using a clinical rating scale — how severe or frequent would those symptoms need to be for this trial to even be worth considering, and does my family member's current symptom level fit that profile?
3Are there already approved or standard-of-care treatments for Alzheimer's-related psychosis that we should try first before exploring an experimental option like this one?
4What would participation actually look like day-to-day — how often would my family member need to come in for visits, and is that realistic given their current cognitive and physical condition?
5If my family member enrolls and then their condition changes or they can no longer tolerate the treatment, what are the options for safely stopping or transitioning to another care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
Timeframe: Baseline and End of Treatment (7 weeks)
. Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
. Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:
Exclusion criteria
. Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
. Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease.
. Evidence of a CNS disorder other than Alzheimer's disease that is the primary cause of, or a significant contributor to the participant's dementia.
. Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
. Has an elevated risk of suicidal behavior
. Has had an amyloid PET brain scan or CSF Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
. Evidence of a clinically significant and/or unstable medical condition that, in the opinion of the investigator or medical monitor, could substantially impair cognition, compromise participant safety, interfere with the participant's ability to comply with study procedures or substantially impair the evaluation of efficacy or safety assessments.
. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma