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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychosis Associated With Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: ML-007C-MA

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials Contact Center; Phone Number: +1 650 839 4380; Email: ML-007C-MA-ADP@maplightrx.com

Study Locations

• Argentina
  • Córdoba, Argentina, X5004AOA
    • Recruiting
    • Clinical Site
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5009BIN
      • Recruiting
      • Clinical Site
• Bulgaria
  • Pernik
    • Pernik, Pernik, Bulgaria, 2304
      • Recruiting
      • Clinical Site
  • Sofia
    • Sofia, Sofia, Bulgaria, 1408
      • Recruiting
      • Clinical Site
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6W 2Z8
      • Not yet recruiting
      • Clinical Site
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • Clinical Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Clinical Site
  • Quebec
    • Lévis, Quebec, Canada, G6V 0C9
      • Recruiting
      • Clinical Site
• Czechia
  • Choceň, Czechia, 565 01
    • Recruiting
    • Clinical Site
• France
  • Toulouse, France, 31059
    • Recruiting
    • Clinical Site
• Romania
  • Bucharest, Romania, 041914
    • Recruiting
    • Clinical Site
• South Korea
  • Daegu, South Korea, 41404
    • Recruiting
    • Clinical Site
  • Incheon, South Korea, 21565
    • Recruiting
    • Clinical Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Clinical Site
    • Scottsdale, Arizona, United States, 85253
      • Recruiting
      • Clinical Site
    • Tucson, Arizona, United States, 85704
      • Recruiting
      • Clinical Site
  • California
    • Anaheim, California, United States, 92805
      • Recruiting
      • Clinical Site
    • Orange, California, United States, 92866
      • Recruiting
      • Clinical Site
    • San Diego, California, United States, 92123
      • Recruiting
      • Clinical Site
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Recruiting
      • Clinical Site
    • Deerfield Beach, Florida, United States, 33442
      • Recruiting
      • Clinical Site
    • Doral, Florida, United States, 33122
      • Recruiting
      • Clinical Site
    • Homestead, Florida, United States, 33033
      • Recruiting
      • Clinical Site
    • Miami, Florida, United States, 33122
      • Recruiting
      • Clinical Site
    • Miami, Florida, United States, 33155
      • Recruiting
      • Clinical Site
    • Miami, Florida, United States, 33186
      • Recruiting
      • Clinical Site
    • Miami, Florida, United States, 33173
      • Recruiting
      • Clinical Site
    • Miami Gardens, Florida, United States, 33014
      • Recruiting
      • Clinical Site
    • Miami Gardens, Florida, United States, 33104
      • Recruiting
      • Clinical Site
    • Naples, Florida, United States, 34105
      • Recruiting
      • Clinical Site
    • Orlando, Florida, United States, 32807
      • Recruiting
      • Clinical Site
    • Tampa, Florida, United States, 33629
      • Recruiting
      • Clinical Site
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Clinical Site
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Recruiting
      • Clinical Site
  • New Jersey
    • West Long Branch, New Jersey, United States, 07764
      • Recruiting
      • Clinical Site
  • Ohio
    • Dayton, Ohio, United States, 45459
      • Recruiting
      • Clinical Site
    • Independence, Ohio, United States, 44131
      • Recruiting
      • Clinical Site
  • Texas
    • Sugarland, Texas, United States, 77478
      • Recruiting
      • Clinical Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Recruiting
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo Tablets
Experimental: ML-007C-MA	Drug: ML-007C-MA; ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score	The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the participant's hallucinations and delusions using the investigator's judgment and past experience with participants who have Alzheimer's disease psychosis. Higher scores on this scale indicate worse outcomes.	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	NPI-C A+A scale includes 2 domains from the NPI-C scale, namely, agitation and aggression. These 2 domains include the following number of items to be rated by the clinician: Agitation, 13 items (maximum score = 39), and Aggression, 8 items (maximum score = 24). The maximum score for the NPI-C A+A scale is 63. Higher scores on this scale indicate more severe symptoms of agitation and aggression.	Baseline and End of Treatment (7 weeks)

Collaborators and Investigators

• Sponsor: MapLight Therapeutics
• Investigators: Study Director: MapLight Therapeutics, MapLight Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Dementia; Alzheimer Disease; Central Nervous System Diseases; Neurodegenerative Diseases; Mental Disorders; Psychotic Disorders; Delusions; Brain Diseases; Hallucinations; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Muscarinic Antagonists; Tauopathies; Cholinergic Agents; Muscarinic Agonists
• Additional Relevant MeSH Terms: Neurologic Manifestations; Behavioral Symptoms; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Psychotic Disorders; Alzheimer Disease; Mental Disorders; Dementia; Brain Diseases; Nervous System Diseases; Neurodegenerative Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Hallucinations; Schizophrenia Spectrum and Other Psychotic Disorders; Tauopathies; Delusions
• Other Study ID Numbers: ML-007C-MA-221; 2024-519820-26-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes