A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
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
2 other identifiers
interventional
300
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2025
CompletedFirst Posted
Study publicly available on registry
March 20, 2025
CompletedStudy Start
First participant enrolled
August 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 9, 2026
May 1, 2025
2.3 years
March 14, 2025
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
Baseline and End of Treatment (7 weeks)
Secondary Outcomes (2)
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
Baseline and End of Treatment (7 weeks)
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory - Clinician Agitation and Aggression (NPI-C A+A) score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline
Baseline and End of Treatment (7 weeks)
Study Arms (2)
ML-007C-MA
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
- Has previously participated in any clinical study with ML-007 or ML-007C-MA.
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Clinical Site
Phoenix, Arizona, 85004, United States
Clinical Site
Scottsdale, Arizona, 85253, United States
Clinical Site
Tucson, Arizona, 85704, United States
Clinical Site
Anaheim, California, 92805, United States
Clinical Site
Orange, California, 92866, United States
Clinical Site
San Diego, California, 92123, United States
Clinical Site
Boca Raton, Florida, 33428, United States
Clinical Site
Deerfield Beach, Florida, 33442, United States
Clinical Site
Doral, Florida, 33122, United States
Clinical Site
Homestead, Florida, 33033, United States
Clinical Site
Miami, Florida, 33122, United States
Clinical Site
Miami, Florida, 33155, United States
Clinical Site
Miami, Florida, 33173, United States
Clinical Site
Miami, Florida, 33186, United States
Clinical Site
Miami Gardens, Florida, 33014, United States
Clinical Site
Miami Gardens, Florida, 33104, United States
Clinical Site
Naples, Florida, 34105, United States
Clinical Site
Orlando, Florida, 32807, United States
Clinical Site
West Palm Beach, Florida, 33407, United States
Clinical Site
Las Vegas, Nevada, 89121, United States
Clinical Site
West Long Branch, New Jersey, 07764, United States
Clinical Site
Independence, Ohio, 44131, United States
Clinical Site
Brampton, Ontario, L6W 2Z8, Canada
Clinical Site
London, Ontario, N6A 5W9, Canada
Clinical Site
Toronto, Ontario, M4N 3M5, Canada
Clinical Site
Lévis, Quebec, G6V 0C9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MapLight Therapeutics
MapLight Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2025
First Posted
March 20, 2025
Study Start
August 15, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 9, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share