An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive impairment (PD-MCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic PD according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet MDS Task Force Criteria for MCI in PD.
- •Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening.
- •Meet criteria for Hoehn & Yahr Stage I to III (mild to moderate motor severity) at Screening.
- •Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of the investigator.
排除标准
- •Have a diagnosis of dementia of any etiology, including but not limited to: Dementia associated with PD (probable or possible), Dementia with Lewy Bodies, Alzheimer's Dementia, and Vascular Dementia.
- •Have any indication of parkinsonism other than idiopathic PD.
- •In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD.
- •Have an ongoing central nervous system condition other than idiopathic PD, including active neurologic and/or nonremitted psychiatric disorders, in the opinion of the investigator.
- •Have a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury.
- •Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.
研究组 & 干预措施
Part A: SAGE-718 3 mg
Participants received SAGE-718 3 milligrams (mg) tablets, once daily with food in the morning for 14 days.
干预措施: SAGE-718 (Drug)
Part B: SAGE-718 3 mg
Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days.
干预措施: SAGE-718 (Drug)
结局指标
主要结局
Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: From first dose of study drug up to 42 days
An AE was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal.
Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: From first dose of study drug up to 28 days
An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal.
次要结局
- Part A and B: Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements(From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B)
- Part A and B: Percentage of Participants With Clinically Significant Changes in Laboratory Assessments(From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B)
- Part A and B: Percentage of Participants With a Response of 'Yes' to Any Suicidal Ideation or Suicidal Behaviors Item Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)(From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B)
- Part A and B: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements(From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B)