Effects of Avandia on Cognition and Cerebral Glucose Utilisation in Subjects With Mild to Moderate Alzheimer's Disease (AD).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12
研究概览
简要总结
This is a placebo-controlled study evaluating the effects of rosiglitazone on functional brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rosiglitazone
4 mg once a day for 1 month increasing to 8 mg once a day (Extended Released Tablets)
干预措施: Rosiglitazone (Drug)
Placebo
Placebo dummy to match
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12
时间窗: Baseline (Day 1) and Month 12
Global CMRGlu index was related to grey matter of brain. Regional CMRGlu index was related to assessment of different regions of brain namely posterior cingulate gyrus, frontal lobe, parietal lobe, posterior temporal lobe, cerebellum, and medial temporal lobe. Evaluation of medial temporal lobe CMRGlu included assessment of medial anterior temporal lobe, paraHippocampal Ambiens gyrus, amygdala, and hippocampus. The regional CMRGlu index is directly proportional to the true metabolic rate of glucose. Baseline was defined as Day 1 of the 12 months treatment period. Change from Baseline is the value at indicated time point minus the Baseline value. Data has been presented for arithmetic mean; however, statistical analysis has been presented for adjusted or least square (LS) mean.
次要结局
- Change From Baseline (Day 1) in CMRGlu Indices at Months 1 and 6(Baseline (Day 1), Months 1, and 6)
- Change From Baseline (Day 1) in Delayed Free Recall Words at Months 1, 6, and 12 by Buschke Selective Reminding (BSR) Test(Baseline (Day 1), and Months 1, 6, and 12)
- Percent Change From Baseline in Brain Volume Over Period(Baseline (Day 1), Month 6, and Month 12)
- Change From Baseline in Fasting Plasma Glucose at Month 12(Baseline (Day 1) and Month 12)
- Change From Baseline in Glycosylated Hemoglobin [HbA1C] at Month 12(Baseline (Day 1) and Month 12)
- Change From Baseline in Lipid (Cholesterol) and Apo-lipoprotein Levels at Month 12(Baseline (Day 1) and Month 12)
- Change From Baseline in Inflammatory Biomarkers (CD40, C-reactive Protein [CRP] , Interleukin [ IL ]-6, and Tumor Necrosing Factor [TNF]-Alpha)(Baseline (Day 1) and Month 12)
- Change From Baseline in Insulin Sensitivity Measured by Homeostasis Model Assessment of Insulin Resistance (HOMA IR)(Baseline (Day 1) and Month 12)
- Number of Participants by Apo-lipoprotein -e (APOE Epsilon)-4 Allele Subtype(Up to 12 months)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 12 months)
- Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Outside the Concern Range at Month 12(At Month 12)
- Change From Baseline (Day 1) in Delayed Free Recall Items Over Period by Stroop Colour Word Interference (SCWI) at Months 1, 6 and 12(Baseline (Day 1), Months1, 6, and 12)
- Change From Baseline (Day 1) in Simplified Spatial Paired Associate Learning (SSPAL) Response Over Period(Baseline (Day 1), Months 1, 6, and 12)
- Change From Baseline (Day 1) in Accuracy by Choice Reaction Time (CRT) Test Over Period(Baseline (Day 1) and up to 12 months)
- Change From Baseline in Cognitive Test by Simple Reaction Time (SRT) Method Over Period(Baseline (Day 1) and up to 12 months)
- Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-COG) Total Score Over Period(Baseline (Day 1), and Months 1, 6, and 12)
- Change From Baseline in Clinician Based Impression of Change-plus (CBIC +) Score Over Period(Baseline (Day 1) and Months 1, 6, and 12)
- Change From Baseline in Neuropsychiatric Inventory Score Over Period(Baseline (Day 1), Months 1, 6 and 12)
- Change From Baseline in Mini-mental State Examination (MMSE) Score Over Period(Baseline (Day 1), and up to Month 12)
- Change From Baseline in Normalized Brain Volume Over Period(Baseline (Day 1), Month 6 and Month 12)
- Number of Participants With Heart Rate/ Pulse Rate Outside the Concern Range at Month 12(At Month 12)
- Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Parameters at Screening and Follow-up(At screening (within 1 month of Day 1) and follow-up period (within 2 weeks of final dose [12 months]))
- Number of Participants With Body Weight and Height Outside the Clinical Concern at Month 12(At Month 12)
- Global and Regional CMRglu Index by APOE Epsilon-4 Allele Subtype at 12 Month(At Month 12)
- Number of Participants With Hematological Data of Potential Clinical Concern (PCC) at End of Treatment (Month 12)(At Month 12)
- Number of Participants With Clinical Chemistry Data of PCC at End of the Treatment (Month 12)(At Month 12)