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临床试验/NCT02772523
NCT02772523已完成不适用

Control and Intervention Programme on Alzheimer's Disease Risk Factors

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation2 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
409
试验地点
2
主要终点
Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire

研究概览

简要总结

Recent epidemiologic studies are identifying a number of modifiable risk and protective factors that may influence in the incidence of Alzheimer's disease (AD). Therefore, the combination of an early detection of individuals at risk together with interventional studies targeted to the control of modifiable risk factors makes primary prevention programmes to become a new and real therapeutic strategy.

In this scenario, the investigators have designed the ALFAlife study, a programme of control and intervention on the modifiable AD risk factors. Throughout this study, participants will be given a number of healthy lifestyle guidelines that are personalised depending on their specific risk profile. These guidelines refer to smoking and dietary habits and physical, cognitive and social activity. The investigators hypothesis is that the follow-up of these guidelines will favor a change of participants' lifestyle habits towards healthier ones. In addition, the investigators hypothesise that changes in these lifestyle habits will have an effect on objective physiological measures (such as blood pressure and cholesterol levels).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants in the ALFA study (NCT01835717)
  • Computer literacy
  • Accept study's tests and procedures
  • Signature of informed consent

排除标准

  • Cognitive impairment assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up.
  • Anxiety or depression assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up.
  • Visual and/or hearing impairment severe enough to impede tests realization.
  • Major psychiatric or neurological disorder or other diseases that according to the investigator's evaluation could interfere with the study's follow-up.
  • Antecedents of infarction, ischemic heart disease, stroke, peripheral vascular disease, stent or aneurysm clip

结局指标

主要结局

Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire

时间窗: 1 year; change between baseline and one year after

Change in 14-item mediterranean diet Questionnaire

时间窗: 1 year; change between baseline and one year after

Change in Lifestyle Activities Questionnaire (LAQ)

时间窗: 1 year; change between baseline and one year after

次要结局

未报告次要终点

研究者

发起方
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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