Multicenter, Observational and Prospective Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors (MEMOGAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 12
- 主要终点
- Changes in cognitive function
研究概览
简要总结
The main objective will be to evaluate the changes in the cognitive function in naive patients treated with PCSK9 inhibitors (Alirocumab and Evolocumab) by using the Montreal Cognitive Assesment questionnaire (MOCA).
The secondary objectives will be: 1) To evaluate the levels of LDL-cholesterol changes from the beginning to the end of the study 2) To evaluate changes in Quality of Life among the EuroQol EQ-5D-3L questionnaire (it will also be associated to the cognitive function) 3) Assesment of direct costs in medications and outpatients consultations related with the health procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years old or over
- •To start with the first funded dose of PCSK9 inhibitors ( LDL > 100 mg/dL)
- •Maximum dose or statin intolerance
排除标准
- •Diagnosis of any disease related with cognitive deterioration
研究组 & 干预措施
Uncontrolled patients with hypercholesterolemia
Patients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab
干预措施: PCSK9 inhibitor (Drug)
结局指标
主要结局
Changes in cognitive function
时间窗: 24 to 36 months
Assesment by Montreal Cognitive Assessment questionnaire (MOCA). Minimum value is 0 and maximum value is 30. A higher or equal value to 26 points will be considered normal.
次要结局
- Direct costs(24 to 36 months)
- LDL-cholesterol values(24 to 36 months)
- Changes in Quality of life(24 to 36 months)
研究者
Jose Seijas Amigo
Pharmacist
Hospital Clinico Universitario de Santiago