XanaMIA-DR a Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Pharmacodynamics and Safety of Xanamem® in Healthy Elderly Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 5
- 主要终点
- Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.
研究概览
简要总结
Xanamem® is being developed as a potential drug for Mild Cognitive Impairment in Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level of cortisol will be a benefit in the treatment of Mild Cognitive Impairment in Alzheimer's disease.
The purpose of this study in older volunteers is to investigate the smallest dose of Xanamem® (5 mg or 10 mg) which works and to investigate which dose in this study will be used in the upcoming clinical trials in patients.
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, Investigator, Outcomes Assessor)
盲法说明
Study treatment is blinded for participants, investigators.
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
- 是
入选标准
- •Male or female aged 50 to 80
- •Body mass index 17.5 to < 35 kg/m2, inclusive at the time of screening
- •Mini-Mental State Score of ≥ 25 points at screening
- •Must provide written informed consent
排除标准
- •Abnormalities in vital signs at screening or baseline
- •Clinically significant abnormal hematology or biochemistry values, as determined by the investigator at screening and/or baseline.
- •Previous clinically significant systemic illness or infection within the past 4 weeks prior to screening or baseline, as determined by the investigator
- •Clinically significant ECG abnormalities
- •Use of tobacco- or nicotine-containing products in the past month or unwillingness to abstain during study participation
- •Participation in another clinical study of a drug or device
- •Known allergy to the study drug (Xanamem®) or any of the excipients
- •Subjects who are likely to be unable to comply with the study schedule and/ or subjects with an inability to communicate well with the investigator
- •Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies at screening
- •Subjects with a history of drug abuse or addiction in the past 5 years.
- •Evidence of alcohol abuse (defined as greater than 21 standard units per week for males and greater than 14 standard units per week for females)
研究组 & 干预措施
Xanamem® 5 mg
Oral Xanamem® capsules 5 mg, to be administered once daily
干预措施: Xanamem® 5 mg (Drug)
Xanamem® 10 mg
Oral Xanamem® capsules 10 mg, to be administered once daily
干预措施: Xanamem® 10 mg (Drug)
Placebo
Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.
时间窗: Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)
Using a tailored Cogstate Neuropsychological Test Battery (NTB), changes from baseline, as well as composite scores based on a combination of these variables at each treatment visit \[Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)\] will be analyzed.
Assessment of safety and tolerability of different Xanamem® doses by the occurrence of Treatment-Emergent Adverse Events (TEAEs).
时间窗: 10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]
The number, type, and severity of Treatment-Emergent Adverse Events (TEAEs) that are reported from Baseline to Follow-up Visit will be collected and evaluated.
次要结局
- Short-term efficacy of different doses of Xanamem® on cognition(Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up))