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ML-007C-MA for hallucinations and delusions in Alzheimer's disease

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis

Phase 2 Interventional MapLight Therapeutics · NCT06887192

This will test whether ML-007C-MA reduces hallucinations and delusions in people aged 55–90 with Alzheimer's-related psychosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorMapLight Therapeutics Industry-sponsored
Locations26 sites (Phoenix, Arizona and 25 other locations)
Trial IDNCT06887192 on ClinicalTrials.gov

What this trial studies

ML-007C-MA-221 is a randomized, double-blind, placebo-controlled Phase 2 trial comparing ML-007C-MA with placebo in men and women aged 55 to 90 who have hallucinations or delusions associated with Alzheimer's disease psychosis. Participants must have psychotic symptoms for at least two months, reside in a stable home or care facility, and have a designated care partner to report symptoms; consent or legally authorized representative approval and participant assent are required. The primary endpoint is change in the Neuropsychiatric Inventory-Clinician Hallucinations + Delusions (NPI-C H+D) score, and safety is monitored throughout the study. Study visits are being conducted at clinical sites in Phoenix, Scottsdale, and Tucson, Arizona.

Who should consider this trial

Good fit: Ideal candidates are people aged 55–90 with possible or probable Alzheimer's disease who have had hallucinations or delusions for at least two months, live in a stable residence, and have a frequent care partner plus capacity or LAR consent and participant assent.

Not a fit: Patients without psychotic symptoms, those outside the 55–90 age range, those who cannot provide consent and lack a legally authorized representative, or those without a reliable care partner or stable residence are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, ML-007C-MA could reduce hallucinations and delusions and improve daily functioning and quality of life for people with Alzheimer's-related psychosis.

How similar studies have performed: Related pharmacologic approaches for dementia-related psychosis have shown mixed results, though agents such as pimavanserin demonstrated benefit in some dementia-related psychosis trials while traditional antipsychotics have notable safety risks.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Phoenix, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Psychosis Associated With Alzheimer's DiseaseAlzheimer DiseaseBrain DiseasesCentral Nervous System DiseasesDelusionsDementiaHallucinationsMental Disorders
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.