Overview

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

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 (or care partner, if local regulations allow) must provide written informed consent AND
   2. The participant will provide written (if capable) informed assent.

2. Aged 55 to 90 years, inclusive, at time of informed consent.
3. Meets clinical criteria for Possible AD or Probable AD.
4. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
5. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
6. 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.
7. 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.
8. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
9. 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 had an amyloid positron emission tomography (PET) brain scan or cerebrospinal fluid (CSF) Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
6. 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.
7. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
8. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
9. Has previously participated in any clinical study with ML-007 or ML-007C-MA.
10. 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).