An Open-label Extension to Study AVA105640, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Adverse Events (AEs) and Severity of AEs
研究概览
简要总结
This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed AVA105640. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 51 Years 至 91 Years（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
Arm 1
Rosiglitazone XR
干预措施: Rosiglitazone XR (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Events (AEs) and Severity of AEs
时间窗: Up to Week 82
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The drug related-AEs of special interest (AESI) was reported. The severity of the AESI was categorized as mild, moderate and severe. Number of participants with AEs were reported for treatment duration of the study.
次要结局
- Number of Participants With Serious AEs and Deaths(Up to Week 82)
- Percentage of Participants With AEs of Edema(Up to 82 Weeks)
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82))
- Change From Baseline in Heart Rate (HR)(Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82))
- Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period(Up to 82 weeks)
- Change From Baseline in Body Weight (BW)(Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82))
- Number of Participants With Abnormal HR at Any Time During Treatment Period(Up to 82 weeks)
- Number of Participants With Hematological Parameters of Potential Clinical Concern(Up to 82 weeks)
- Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status(Baseline (Visit 1, W0), W 24 and W 52)
- Number of Participants With Abnormal BW at Any Time During Treatment Period(Baseline (Visit 1, W0) to W 52)
- Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.(Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82)
- Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern(Up to 82 weeks)
- Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status(Baseline (Visit 1, W0), W24 and W52)
- Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score as a Function of Apolipoprotein E (APOE) 4 Status at W24 and W52(Baseline (Visit 1, W0), W24 and W52)
- Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52(Baseline (Visit 1, W0), W 24 and W52)
- Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52(Baseline (Visit 1, W0), W24 and W52)
- Change From Baseline in Glycosylated Haemoglobin (HbA1c)(Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82))