An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy 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
- 1,461
- 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 either AVA102670 or AVA102672. 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 as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. 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 either AVA102670 or AVA102672. 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
- Na
- 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
Rosiglitazone XR
Investigational drug
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 76 Weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.
次要结局
- Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Up to 70 Weeks (including follow up))
- Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides(Up to 82 Weeks (including follow up))
- Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)(Up to 70 Weeks (including follow up))
- Number of Participants With HR Values of PCC ATOT(Up to 70 Weeks (including follow up))
- Number of Participants With BW Values of PCC ATOT(Up to 70 Weeks (including follow up))
- Number of Participants With Hematology Parameters of PCC ATOT(Up to Week 82 (including follow up))
- Number Participants With Serious Adverse Events (SAEs) and Deaths(Up to 76 Weeks)
- Number of Participants With Adverse Event of Oedema(Up to 76 Weeks)
- Change From Baseline in Vital Sign Body Weight (BW)(Up to 70 Weeks (including follow up))
- Change From Baseline in Vital Sign Heart Rate (HR)(Up to 70 Weeks (including follow up))
- Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT(Up to Week 82 (including follow up))
- Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.(Baseline (Week 0) and Week 24, 52)
- Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.(Baseline (Week 0) and Week 24, 52)
- Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.(Baseline (Week 0) and Week 24, 52)
- Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.(Baseline (Week 0) and Week 24, 52)
- Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.(Baseline (Week 0) and Week 24, 52)