An Open-Label Study of ML-007C-MA in Adults 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).

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Key information

Conditions

Psychosis Associated With Alzheimer's Disease Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Delusions Dementia Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Tauopathies

Age range

55 year–91 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Site, Doral, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

ML-007C-MA

Drug

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

Primary outcomes

To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD

Time frame: From initial dose through end of treatment (up to 52 weeks)

using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Contact Center

CONTACT

[email protected]

+1 650 839 4380

Sponsors and collaborators

Lead sponsor

MapLight Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Mar 10, 2026
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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