An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis

An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML007C-MA in Adult Participants With Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis

ML-007C-MA-222 is a 52-week, flexible-dose, open-label extension study designed to evaluate the long-term safety, tolerability, and effectiveness of ML007C-MA in participants with ADP who have completed the antecedent study (ie, Study ML-007C-MA-221).

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 210
• 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

• United States
  • Florida
    • Doral, Florida, United States, 33122
      • Recruiting
      • Clinical Site
    • Miami, Florida, United States, 33155
      • Recruiting
      • Clinical Site
    • Miami, Florida, United States, 33173
      • Recruiting
      • Clinical Site

Participation Criteria

Eligibility Criteria

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

Description

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. Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).
3. May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.
4. Has a designated study care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
5. Resides in a stable living environment (eg, home, residential assisted living, or nursing home facility) and is expected to remain in the living situation throughout the study.

Exclusion Criteria

1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
2. Requires treatment with protocol-defined prohibited medications.
3. Has developed a new or worsening medical comorbidity during or since the antecedent study that, in the opinion of the investigator and/or medical monitor, would compromise participant safety, interfere with the participant's ability to comply with study procedures, would preclude obtaining voluntary consent/assent, and/or would substantially impair the evaluation of study assessments.
4. Has or had a clinically significant abnormal physical examination, vital sign, ECG or clinical laboratory safety result during or since the antecedent study that would compromise participant safety, interfere with the participant's ability to comply with study procedures, and/or would confound the interpretation of the outcome measures in the study in the opinion of the investigator.
5. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study.
6. Has an elevated risk of suicidal behavior.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD	using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.	From initial dose through end of treatment (up to 52 weeks)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

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-222; 2025-521757-16-00 (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