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

NCT07459660 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ML-007C-MA-2222025-521757-16-00
• Study Type: interventional
• Target: 210
• Locations: 3 countries
• Sites: 8

Brief Summary

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).

Conditions

Psychosis Associated With Alzheimer's Disease

Keywords

Alzheimer Disease; Brain Diseases; Central Nervous System Diseases; Delusions; Dementia; Hallucinations; Mental Disorders; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Tauopathies; Muscarinic Antagonists; Muscarinic Agonists; Cholinergic Agents

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

ML-007C-MA

EXPERIMENTAL

Drug: ML-007C-MA

Interventions

ML-007C-MA DRUG

ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID

ML-007C-MA

Eligibility Criteria

• Age: 55 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).
• May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.
• 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.
• 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.

You may not qualify if:

• Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
• Requires treatment with protocol-defined prohibited medications.
• 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.
• 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.
• Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study.
• Has an elevated risk of suicidal behavior.

Sponsors & Collaborators

• MapLight Therapeutics: lead

Study Sites (8)

Clinical Site

Anaheim, California, 92805, United States

RECRUITING

Clinical Site

Doral, Florida, 33122, United States

RECRUITING

Clinical Site

Miami, Florida, 33155, United States

RECRUITING

Clinical Site

Miami, Florida, 33173, United States

RECRUITING

Clinical Site

Miami Gardens, Florida, 33014, United States

RECRUITING

Clinical Site

Orlando, Florida, 32807, United States

RECRUITING

Clinical Site

Pernik, Pernik, 2304, Bulgaria

RECRUITING

Clinical Site

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Brain Diseases; Central Nervous System Diseases; Delusions; Dementia; Hallucinations; Mental Disorders; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Tauopathies

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MapLight Therapeutics

  MapLight Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Contact Center

CONTACT

+1 650 839 4380; ML-007C-MA-ADP@maplightrx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); BU (1); US (6)