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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Site
  Phoenix, Arizona, United States Recruiting
• Clinical Site
  Scottsdale, Arizona, United States Recruiting
• Clinical Site
  Tucson, Arizona, United States Recruiting
• Clinical Site
  Anaheim, California, United States Recruiting
• Clinical Site
  Long Beach, California, United States Recruiting
• Clinical Site
  Murrieta, California, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Contact Center
• Email: ML-007C-MA-ADP@maplightrx.com
• Phone: +1 650 839 4380

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• KarXT for psychosis in people with Alzheimer's disease

  This Phase 3 test will see if KarXT reduces hallucinations and delusions in people aged 55–90 who have Alzheimer's-related psychosis.

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• Understanding brain mechanisms of psychosis in Alzheimer's disease

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  Recruiting Northwell Health · Manhasset, New York · NCT05847192

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.