An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive and neuropsychiatric symptoms in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD).
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant meets the following criteria for MCI or mild dementia due to AD at Screening: has a memory complaint, has clinical dementia rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5, has essentially preserved activities of daily living
- •Participant has a score of 15 to 24 (inclusive) on the Montreal Cognitive Assessment at Screening
- •Participant has normal premorbid intelligence quotient (IQ) at Screening
- •Participant has a study partner who is reliable, competent, at least 18 years of age, willing to be available to the study center by phone, support study-specific activities, and accompany the participant to study visits as needed
排除标准
- •Participant has any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline
- •Participant has 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
- •Participant has a history, presence, and/or current evidence of a clinically-significant intracranial abnormality (eg, stroke, hemorrhage, space-occupying lesion) that could account for the observed cognitive impairment (excluding abnormalities consistent with underlying AD pathology)
- •Participant has a history of possible or probable cerebral amyloid angiopathy, according to the Boston Criteria
- •Participant has a history of seizures or epilepsy, with the exception of a single episode of febrile seizures in childhood
- •Participant has current or recent suicidality
研究组 & 干预措施
SAGE-718
Participants received SAGE-718 3 mg oral tablets, once daily in the morning for 14 days.
干预措施: SAGE-718 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From first dose of study drug up to last follow up visit (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 the 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.
次要结局
- Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements(From first dose of study drug up to last follow-up visit (up to 28 days))
- Percentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments(From first dose of study drug up to last follow-up visit (up to 28 days))
- Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements(From first dose of study drug up to last follow-up visit (up to 28 days))
- Percentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to Day 28)