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临床试验/NCT03173846
NCT03173846已完成不适用

Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年5月5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
90
试验地点
1
主要终点
Change in cognition

研究概览

简要总结

This study aims to predict cognitive decline using a performance endophenotype of neuro-feedback based on functional magnetic resonance imaging in real time in a population at risk for Alzheimer's disease (AD).

详细描述

In this research project, a longitudinal study in a healthy population that is under increased risk of developing AD will be performed. It is anticipated that some of the participating subjects will develop episodic memory decline within this longitudinal follow-up. The memory binding Test (MBT) and/or the Free and Cued Selective Reminding Test (FCSRT), the most accurate and reliable available episodic memory tests, are going to be performed by the subjects at multiple longitudinal data collection points. The project proposes to develop a real-time functional magnetic resonance imaging (rtfMRI) task, and to test whether the subjects' performance on the task can predict the apparition of cognitive decline. The impact of other relevant biomarkers by adding them to the model: age, gender, number of APOE-e4 alleles, cognitive scores, cerebrospinal fluid (CSF) biomarkers, amyloid Positron Emission Tomography (PET), lifestyle habits and clinical background will be studied.

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
45 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men and women (aged 45-75) that have participated in the study 45-65/FPM
  • Persons that accept the study's test and procedures that are as follows: magnetic resonance imaging and neuropsychological tests.
  • Signature of the study's informed consent form, accepting to not receive information with regards to any research results that are not clinically relevant.

排除标准

  • Any contraindication to MRI (e.g. pacemaker, claustrophobia, etc.)
  • Any condition that according to the investigator's judgement could interfere with the proper execution of the study's procedures and/or its follow-up.

结局指标

主要结局

Change in cognition

时间窗: 12 months

Predictive value of neurofeedback performance

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 (1)

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