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

NCT ID: NCT06887192
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: MapLight Therapeutics
Conditions: Psychosis Associated With Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 300 participants (Estimated).

What is being studied

Drug: ML-007C-MA
Drug: Placebo

Who may be eligible

Ages: 55 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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).

Study locations

56 study locations are listed.

Recruiting site status is explicitly provided for 56 locations; 55 are listed as Recruiting.

Countries: Argentina, Bulgaria, Canada, Chile, Czechia, France, Hungary, Italy, Poland, Portugal, Romania, Serbia, Slovakia, South Korea, United States

Buenos Aires F.D., Argentina: 1
Córdoba Province, Argentina: 1
Pernik, Bulgaria: 1
Sofia, Bulgaria: 1
Ontario, Canada: 3
Quebec, Canada: 1
Antofagasta, Chile: 1
Lisbon District, Portugal: 1
Arizona, United States: 3
California, United States: 5
Colorado, United States: 1
Florida, United States: 10
Georgia, United States: 2
Louisiana, United States: 1
Nevada, United States: 1
New Jersey, United States: 1
New York, United States: 1
Ohio, United States: 2
Oregon, United States: 1
South Carolina, United States: 1
Texas, United States: 3
Washington, United States: 1

Sample of listed locations

Clinical Site — Caba, Buenos Aires F.D., C1133AAH, Argentina — Recruiting
Clinical Site — Córdoba, Córdoba Province, X5009BIN, Argentina — Recruiting
Clinical Site — Córdoba, X5004AOA, Argentina — Recruiting
Clinical Site — Pernik, Pernik, 2304, Bulgaria — Recruiting
Clinical Site — Sofia, Sofia, 1408, Bulgaria — Recruiting
Clinical Site — London, Ontario, N6A 5W9, Canada — Recruiting
Clinical Site — Toronto, Ontario, M4N 3M5, Canada — Recruiting
Clinical Site — Lévis, Quebec, G6V 0C9, Canada — Recruiting
Clinical Site — Antofagasta, Antofagasta, 1240000, Chile — Recruiting
Clinical Site — Santiago, 7500710, Chile — Recruiting
Clinical Site — Choceň, 565 01, Czechia — Recruiting
Clinical Site — Prague, 150 00, Czechia — Recruiting
Clinical Site — Toulouse, 31059, France — Recruiting
Clinical Site — Pécs, 7623, Hungary — Recruiting
Clinical Site — Roma, 00128, Italy — Recruiting
Clinical Site — Plewiska, 62-064, Poland — Recruiting
Clinical Site — Torres Vedras, Lisbon District, 2560-280, Portugal — Recruiting
Clinical Site — Bucharest, 041914, Romania — Recruiting
Clinical Site — Kragujevac, 34000, Serbia — Recruiting
Clinical Site — Vranov nad Topľou, 093 01, Slovakia — Recruiting
Clinical Site — Daegu, 41404, South Korea — Recruiting
Clinical Site — Incheon, 21565, South Korea — Recruiting
Clinical Site — Phoenix, Arizona, 85004, United States — Recruiting
Clinical Site — Scottsdale, Arizona, 85253, United States — Recruiting
Clinical Site — Tucson, Arizona, 85704, United States — Recruiting

Study details

Start date: August 15, 2025
Primary completion date: December 1, 2027
Completion date: December 1, 2027
First posted: March 20, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06887192
Registry last updated: September 30, 2026
QualifiedStudies registry data refreshed: October 12, 2026
QualifiedStudies record fetched: October 12, 2026

View NCT06887192 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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