The SARTAN-AD Trial: A Randomized, Open Label, Proof of Concept Study of Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Safety - Electrolytes
研究概览
简要总结
To conduct a proof of concept study in patients with mild to moderate Alzheimer's Disease in order to determine if there is less global brain atrophy over one year, as measured by ventricular enlargement as a primary outcome measure, when patients are randomized to treatment with an angiotensin receptor blocker (ARB) compared to an angiotensin converting enzyme inhibitor (ACEI).
详细描述
This study uses a simple validated measure of brain atrophy as a surrogate marker in a repurposing effort that could recast an antihypertensive medication as a cognitive enhancer/neuroprotective agent and possibly as a drug of choice for Alzheimer patients and patients at risk for AD. If the proof of concept result is positive, a larger study would be warranted with potential practice-changing impact.
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
- None
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
Telmisartan
Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)
干预措施: Telmisartan (Drug)
Perindopril
Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)
干预措施: Perindopril (Drug)
结局指标
主要结局
Safety - Electrolytes
时间窗: 12 months
Change in electrolyte measurements (Na, K) after 12 months of treatment.
Ventricular enlargement
时间窗: 12 months
Change in ventricular size, on 3D T1 MR imaging, after 12 months of treatment
Safety - Vital signs
时间窗: 12 months
Change in vital sign (heart rate, pulse) measurements after 12 months of treatment.
Safety - Adverse Events
时间窗: 12 months
Adverse events and serious adverse events over 12 months of treatment.
Safety - Blood pressure
时间窗: 12 months
Change in blood pressure (BP) measurements after 12 months of treatment.
次要结局
- Grey/White matter volume(12 months)
- Cognitive and functional measures(6 and 12 months)
- Hippocampal volume(12 months)
研究者
Dr. Sandra E Black
Principal Investigator
Sunnybrook Health Sciences Centre