NCT06887192 A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
| NCT ID | NCT06887192 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | MapLight Therapeutics |
| Condition | Psychosis Associated With Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2025-08-15 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key 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. Meets clinical criteria for Possible AD or Probable AD. 3. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening. 4. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening. 5. 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. 6. Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria: 1. Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR 2. Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items. 7. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4 8. Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive. Key Exclusion Criteria: 1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care. 2. Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease. 3. 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. 4. Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria. 5. Has an elevated risk of suicidal behavior 6. 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. 7. 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. 8. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma 9. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine). 10. Has previously participated in any clinical study with ML-007 or ML-007C-MA. 11. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients. 12. Received or may have received an investigational drug, biological product or device within 90 days before Baseline (or 6 months for investigational Alzheimer's disease-modifying therapies).
Contact & Investigator
MapLight Therapeutics
STUDY DIRECTOR
MapLight Therapeutics
Frequently Asked Questions
Who can join the NCT06887192 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 90 Years, studying Psychosis Associated With Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06887192 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06887192 currently recruiting?
Yes, NCT06887192 is actively recruiting participants. Contact the research team at ML-007C-MA-ADP@maplightrx.com for enrollment information.
Where is the NCT06887192 trial being conducted?
This trial is being conducted at Phoenix, United States, Scottsdale, United States, Tucson, United States, Anaheim, United States and 11 additional locations.
Who is sponsoring the NCT06887192 clinical trial?
NCT06887192 is sponsored by MapLight Therapeutics. The principal investigator is MapLight Therapeutics at MapLight Therapeutics. The trial plans to enroll 300 participants.
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