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Enrolling by invitation NCT07459660

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

Phase II Interventional Psychosis Associated With Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ML-007C-MA.
Who it may be relevant to
Registry conditions: Psychosis Associated With Alzheimer's Disease. Basic parameters: 55 years — 91 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

Interventions

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

Primary outcome measures

  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Clinical Site — Anaheim
  • Clinical Site — Doral
  • Clinical Site — Miami
  • Clinical Site — Miami
  • Clinical Site — Miami Gardens
  • Clinical Site — Orlando
Bulgaria · 1 center
  • Clinical Site — Pernik
France · 1 center
  • Clinical Site — Toulouse

Identifiers

NCT: NCT07459660 · ML-007C-MA-222 · 2025-521757-16-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗