An Open-label Extension of SPG302-ALZ-101 Study to Evaluate the Long-term Safety and Efficacy of Daily Oral SPG302 Treatment in Participants With Mild-to-Moderate Alzheimer's Disease (AD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Treatment emergent adverse events and serious adverse events
研究概览
简要总结
This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALZ-101 with mild to moderate Alzheimer's Disease (AD)
详细描述
This is an open-label extension study of SPG302-ALZ-101 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with mild-to-moderate AD. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild to moderate AD
- •Clinical laboratory values within normal range or < 1.5 times ULN
- •Life expectancy of >2 years
- •Able and willing to provide written informed consent
- •Must have participated in all study activities of SPG302-ALZ-101, the parent study
排除标准
- •Any physical or psychological condition that prohibits study completion
- •Known cardiac disease
- •Active or history of malignancy in the past 5 years
- •Serious infection that will not be resolved by first day of study intervention.
- •History of clinically significant CNS event or diagnosis in the past 5 years.
- •Acute illness within 30 days of Day 1
- •History of suicidal behavior or suicidal ideation
- •History of chronic alcohol use or substance abuse in the last 5 years
- •HIV, hepatitis B and/or hepatitis C positive
- •Vaccines within 14 days
- •Receipt of investigational products within 30 days
- •Blood donation within 30 days
- •Pregnant or breastfeeding
研究组 & 干预措施
Open Label Extension
Active SPG302 to be administered to adult participants with AD who completed initial study. Dose to be administered to be dose received during previous study.
干预措施: SPG302 (Drug)
结局指标
主要结局
Treatment emergent adverse events and serious adverse events
时间窗: Up to 52 weeks
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
C-SSRS (Columbia Suicide Severity Rating Scale)
时间窗: Up to 52 weeks
Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale evaluates the level of actual or potential medical damage. The range is 0-25.Min is 0 and Max is 25.
次要结局
- Change in Mini-Mental State Examination (MMSE) from baseline to endpoint(up to 52 weeks)
- Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint(up to 52 weeks)
- Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint(up to 52 weeks)
- Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint(up to 52 weeks)
- Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint(up to 52 weeks)
- Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint.(up to 52 weeks)
- Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint.(up to 52 weeks)