NCT07459660Enrolling By Invitation2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 210
- 试验地点
- 16
- 主要终点
- To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 91 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ML-007C-MA
Experimental
干预措施: ML-007C-MA (Drug)
结局指标
主要结局
To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD
时间窗: From initial dose through end of treatment (up to 52 weeks)
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
次要结局
未报告次要终点
研究者
研究点 (16)
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