A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease … (NCT06887192) | Clinical Trial Compass
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
United States300 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range55 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
What they're measuring
1
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
Timeframe: Baseline and End of Treatment (7 weeks)
. Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
✕. 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.
✕. Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
✕. Has an elevated risk of suicidal behavior
✕. 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.
✕. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma