A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the H3 Receptor Antagonist, GSK239512 in Subjects With Mild to Moderate Alzheimer's Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Change from Baseline (Day 1) in the episodic memory composite score in the CogState battery at Week 16
研究概览
简要总结
This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with mild to moderate Alzheimer's disease
详细描述
This is a 16-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in male and female subjects with mild to moderate Alzheimers disease (AD). Subjects will undergo 2-week placebo run-in period before randomisation. They will undergo weekly review of safety, tolerability and cognitive performance measures.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GSK239512
Oral tablets
干预措施: GSK239512 (Drug)
Placebo
Placebo to match GSK239512.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline (Day 1) in the episodic memory composite score in the CogState battery at Week 16
时间窗: Baseline (Day 1) and Week 16
Episodic memory composite score was calculated from the three tasks International Shopping List Task (ISLT) immediate recall, ISLT delayed recall, and Paired Associate Learning (PAL). The Total Score was calculated by taking the mean of all individual task scores. Change from Baseline is the value at indicated time point minus the Baseline value.
Change from Baseline (Day 1) in the executive function/working memory composite score in the Cog State battery at Week 16
时间窗: Baseline (Day 1) and Week 16
Executive function/working memory composite score was calculated from the three tasks controlled oral word association (a measure of language fluency, planning and working memory where participants were instructed to generate as many as words as they could think of beginning with a specific letter in one minute. They were then requested to do exactly the same for two furthers letters and a score was given for this activity accuracy), category naming (a measure of semantic fluency, planning and working memory where participants were required to generate as many exemplars of the category 'animals' as they could in one minute), and one-back (a valid measure of working memory where participants were shown a single stimulus of a card in the center of the computer screen and were asked for YES" or "NO" to match the current card with the previous card and the accuracy was noted). Change from Baseline is the value at indicated time point minus the Baseline value.
次要结局
- Change from Baseline (Day 1) in Mini Mental State Examination (MMSE) total score at Week 16(Baseline (Day 1) and Week 16)
- Clinician's Interview-Based Impression of Change-plus (CIBIC+) score at Weeks 8 and 16.(At Week 8 and 16)
- Participant's Global Impression of Change (PGIC) score, Carer's Global Impression of Change (CrGIC) score, and Clinician Global Impression of Change (CGIC) at Week 8 and 16(Week 8 and 16)
- Change from baseline in the Neuropsychiatric Inventory (NPI) at Weeks 8 and 16(Baseline (Day 1), Week 8, and 16)
- Change from Baseline (Day 1) in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) total score at Weeks 8 and 16(Baseline (Day 1), Week 8, and 16)
- Change from Baseline for Bilateral Score from Olfaction Test at Week 16(Baseline (Day 1) and Week 16)
- Change from Baseline (Day 1) in the attention composite score in the CogState battery at Week 16.(Baseline (Day 1) and Week 16)
- Change from Baseline (Day 1) to Weeks 8 and 16 of the Disability Assessment for Dementia scale (DAD) total score(Baseline (Day 1), Week 8, and Week 16)
- Number of participants with vital signs outside clinical concern range (Systolic blood pressure [SBP], diastolic blood pressure [DBP], and heart rate [HR])(Up to Week 18)
- Change from baseline during the titration phase, and to Weeks 8 and 16 of the Pittsburgh Sleep Quality Inventory (PSQI) and Epworth Sleepiness Scale (ESS)(At Week 8 and 16)
- Plasma concentrations of GSK239512 over period(Up to Week 16)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to 18 weeks)
- Number of participants with abnormal electrocardiogram (ECG) over period(Up to 18 weeks)
- Number of participants with hematological and clinical chemistry parameters outside the reference range up to 16 weeks(Up to 16 weeks)