NCT02573740终止1 期
A Study to Evaluate the Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of Multiple Doses of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease
AbbVie9 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 9
- 主要终点
- Percentage of participants reporting treatment-emergent adverse events
研究概览
简要总结
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female participants must have negative results for pregnancy test performed on a serum sample obtained at Screening
- •Body Mass Index is 18.0 to 35.0 at Screening
- •Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease (AD).
- •Meets the NIA-AA core clinical criteria for Mild Cognitive Impairment due to AD
排除标准
- •Use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration
- •Consumption of alcohol within 24 hours prior to study drug administration
- •Positive screen for non-prescribed drugs of abuse or alcohol
- •The participant has clinically significant abnormal laboratory values at Screening as determined by the investigator
- •History of a drug or alcohol abuse within 6 months prior to study drug administration
- •Current diagnosis of major depression or other major psychiatric disorder
研究组 & 干预措施
ABT-957
Experimental
ABT-957 given twice a day for 84 days
干预措施: ABT-957 (Drug)
Placebo
Placebo Comparator
Placebo given twice a day for 84 days
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of participants reporting treatment-emergent adverse events
时间窗: For approximately 84 days
Level of spectrin breakdown product-145 (SBDP-145)
时间窗: 84 days
次要结局
未报告次要终点
研究者
研究点 (9)
Loading locations...
相似试验
终止
1 期
Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19Healthy VolunteersCOVID-19NCT05184218IGM Biosciences, Inc.26
已完成
1 期
A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD)NCT06748079Chia Tai Tianqing Pharmaceutical Group Co., Ltd.113
已完成
1 期
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Male SubjectsHealthyNCT03214614Galapagos NV39
终止
1 期
Study on Tolerability of Repeat i.c.v. Administration of sNN0031 Infusion Solution in Patients With PDParkinson's DiseaseNCT02408562Newron Sweden AB1
已完成
1 期
Evaluation of Safety and Efficacy of Estetrol in Healthy MenProstatic NeoplasmsNCT02718378Pantarhei Oncology B.V.45