2025-521757-16-00招募中2 期
An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Maplight Therapeutics Inc.29 个研究点 分布在 9 个国家目标入组 85 人开始时间: 2026年5月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 29
- 主要终点
- Incidence of TEAEs, treatment-emergent SAEs, and TEAEs leading to study discontinuation
研究概览
简要总结
To evaluate the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with ADP
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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: a. The participant’s LAR must provide written informed consent. AND b. The participant will provide written (if capable) informed assent.
- •Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007-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 meets the following criteria: a. Study care partner is in contact with the participant frequently enough to accurately report on the participant’s symptoms and on participant’s compliance with taking the study drug, in the investigator’s opinion b. Study care partner is fluent in the local language in which the study assessments will be administered. c. Study care partner agrees to participate in study assessments, accompany the participant to each study visit, and provide written consent to participate in the study.
- •Has sufficient verbal ability to satisfactorily comply with study procedures (corrective measures such as hearing aids and reading glasses are allowed, if necessary) and is willing and able to attend clinic visits. Participants who can attend clinic visits using a wheelchair or other ambulatory assistive device are permitted.
- •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.
- •Women of childbearing potential and men who are sexually active with women of childbearing potential must be willing to adhere to contraception requirements and ova/sperm donation restrictions (Section 13.2). Women must meet 1 of the following criteria to be considered not of childbearing potential: a. Postmenopausal (spontaneous amenorrhea for at least 12 months before dosing without alternative medical explanation) and confirmation by documented FSH levels ≥40 mIU/mL. b. Surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral salpingectomy at least 3 months before dosing).
排除标准
- •Requires treatment with protocol-defined prohibited medications (Table 3)
- •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 confound the interpretation of the outcome measures in the study.
- •Currently 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 substantially confound the interpretation of the outcome measures in the study in the opinion of the investigator. (Note: Immediate Rollover participants may enter this study before laboratory test values and central ECG reports from the Screening/Baseline Visit (ie, Visit 1E/EOT visit of the antecedent study) are received from the central lab and ECG vendors.)
- •At an elevated risk of suicidal behavior based on 1) investigator judgment, 2) history of suicidal behavior during or since the antecedent study, or 3) GCAS clinician score of 3 or 4 at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers).
- •Positive pregnancy test at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers), or is lactating.
- •Allergy or other intolerance to ML-007 or their excipients.
- •Participant or study care partner is an employee or a family member of an employee of MapLight Therapeutics, Inc. or the investigator/study center.
- •Judged by the investigator or Sponsor to be inappropriate for the study, including participants who were insufficiently adherent to study drug or study drug procedures in the antecedent study.
研究组 & 干预措施
null
Test
干预措施: null (Drug)
结局指标
主要结局
Incidence of TEAEs, treatment-emergent SAEs, and TEAEs leading to study discontinuation
Incidence of TEAEs, treatment-emergent SAEs, and TEAEs leading to study discontinuation
次要结局
- Safety: • Observed values and changes from OL Baseline in clinical safety laboratory assessments, 12-lead ECG parameters, vital sign parameters, and body weight • GCAS score • Changes from OL Baseline in ESRS-A score • Changes from OL Baseline in MMSE score
- Effectiveness: Changes from OL Baseline in the following: • NPI-C H+D score • CGI-S hallucinations and delusions domain-specific score • NPI-C A+A score in participants who had a CGI-S agitation and aggression domain-specific score of ≥4 at OL Baseline • ADCS-ADL total score
- Effectiveness: Changes from OL Baseline in ZBI-12 score
- Pharmacokinetic: Plasma concentrations of ML-007 (and its major metabolites, if applicable)
研究者
to be assigned
Scientific
Maplight Therapeutics Inc.
研究点 (29)
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