A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis

Korábbi kezelés

• Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
• Has previously participated in any clinical study with ML-007 or ML-007C-MA.
• 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).

Más betegség

• 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.
• 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.
• Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
• Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.

Egyéb

• Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
• Has an elevated risk of suicidal behavior
• Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma

• 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.
• 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:
  • Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR
  • Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.
• Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
• Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.