A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients With Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Placebo-Controlled
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
研究概览
简要总结
This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.
详细描述
A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Designed as a Randomized, Double-Blind, Multi-Center, Parallel Group, Placebo-Controlled Study
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)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient and study partner to sign informed consent before initiation of any study-related procedures.
- •Clinical diagnosis of Alzheimers (AD) or mild cognitive impairment (MCI) disease.
- •Single caregiver for at least 6 months prior to Screening, capable of accompanying the patient on clinic visits as needed. The caregiver must either be living with or visiting the patient at least 10 hours per week, split over multiple (at least 2) days, for the duration of the study.
- •Single study partner, for at least several months prior to Screening, capable of accompanying the patient on clinic visits as needed. The study partner must either be living with or visiting the patient at least 3 days per week for the duration of the study.
- •A body mass index (BMI=weight/height2) of 18 kg/m2 to 32 kg/m2.
排除标准
- •Significant neurological disease or dementia other than AD or MCI.
- •Current episode or symptoms of major depressive disorder or other major psychiatric disorder.
- •History of self-reported sleep duration of less than 4 hours per night or less than 4 hours average total sleep time per night during Baseline PSG assessment.
- •History or present symptoms of a sleeping disorder such as sleep apnea.
- •History of cancer in the last 5 years.
- •Use of anti-AD drugs (including off-label drugs and herbal medications) with the exception of donepezil, memantine, and/or rivastigmine transdermal system, as monotherapy or in combination in the following conditions: treatment with donepezil (5 mg to 10 mg daily), memantine, and/or rivastigmine transdermal system or combination regimens for at least 3 months and a stable dose(s) for the last 2 months prior to randomization is allowed.
研究组 & 干预措施
AZD5213 doseA
AZD5213 doseA daily
干预措施: AZD5213 (Drug)
AZD5213 doseB
AZD 5213 doseB daily
干预措施: AZD5213 (Drug)
AZD5213 doseC
AZD5213 doseC daily
干预措施: AZD5213 (Drug)
Placebo
Placebo daily
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
时间窗: Baseline and Week 4.
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
次要结局
- Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.(Baseline and Week 4.)
- Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.(Baseline and Week 4.)
- Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.(Baseline and Week 4.)
- Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.(Baseline and Week 4.)
- Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.(Baseline and Week 4.)