Memento-Plus : Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,028
- 试验地点
- 26
- 主要终点
- Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease)
研究概览
简要总结
Dementia is a clinical syndrome that is the result of distinct underlying pathologies including Alzheimer's disease (AD). Despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive.
Many features of dementia render it especially challenging. Indeed development of disease occurs insidiously over the course of years or decade. In addition, the causes of dementia and determinants of its severity are likely multi-factorial.
To overcome these challenges and better understand the causes and course of AD and related disorders, long term follow-up studies of persons at high risk of dementia are required including multidimensional and harmonized assessment of risk factors, phenotypes (cognition, neuropsychiatric symptoms, physical health, self rated health) and endophenotypes (blood markers, genetic markers, neuroimaging markers).
This project proposes an extension of the follow-up of Memento participants over 5 to 10 years with of focus on cognitive outcomes and comorbidities.
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
- •Participants aged over 18 year-old
- •Being included in Memento cohort
- •Affiliated person or beneficiary of a social security scheme.
- •Participants capable of expressing non objection
- •Non objection expressed by the tutor for participants under tutorship
- •Non objection expressed by the participant assisted by their guardian for participants under guardianship
- •Non objection expressed by the trusted person (in accordance with art. L1111-6 of Code de la Santé Publique) for participants without the capacity to express non-objection and who are not under legal protection measure
排除标准
- •Expressing opposition to participate in Memento-Plus
结局指标
主要结局
Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease)
时间窗: Each 12 months from baseline for 5 years
次要结局
- Mortality(Each 12 months from baseline for 5 years)
- Quality of life: EQ-5D (EUROQOL)(Each 12 months from baseline for 5 years)
- Loss of autonomy based on functional activity assessment(Each 12 months from baseline for 5 years)
- Rate of cognitive decline based on change in cognitive performances(Each 12 months from baseline for 5 years)
- Incidence of neurovascular and cardiovascular events (Stroke and Coronary events)(Each 12 months from baseline for 5 years)
- Incidence of prodromal AD (Pre-symptomatic dementia)(Each 12 months from baseline for 5 years)
- Incidence of institutionalization(Each 12 months from baseline for 5 years)