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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD [Срок оценки: From initial dose through end of treatment (up to 52 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Clinical Site — Anaheim
• Clinical Site — Doral
• Clinical Site — Miami
• Clinical Site — Miami
• Clinical Site — Miami Gardens
• Clinical Site — Orlando

Болгария · 1 центр

• Clinical Site — Pernik

Франция · 1 центр

• Clinical Site — Toulouse

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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