跳至主要内容
临床试验/NCT05709210
NCT05709210进行中(未招募)不适用

Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2023年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
71
试验地点
1
主要终点
Comparison of a mathematical combination

研究概览

简要总结

This study will compare smartphone usage data between three groups of patients diagnosed with either a memory complaint, mild cognitive decline, or Alzheimer's disease.

详细描述

Alzheimer's disease (AD) is the leading cause of dementia in the world. The first cognitive function affected is memory and then other cognitive systems are affected leading to a progressive loss of autonomy of the patient. Currently, the diagnosis of AD is made at too late a stage. Patients with memory complaints or mild cognitive decline (MCI) are particularly at risk of developing AD.

However, there is no clinical or paraclinical evidence to predict precisely this risk of progression to AD. Investigator's hypothesis is that there is an association between the evolution of smartphone use and the conversion of cognitive status to AD.

The purpose of this pilot study is to identify existing differences between smartphone use data of patients with a memory complaint or of patients MCI or with an AD. It is a study of 90 patients (30 patients with memory complaint, 30 with MCI and 30 with AD) with a collection of smartphone usage data during three months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patient consulting in routine care in one of the CMRR
  • No sensory impairment that may compromise smartphone use

排除标准

  • Inability to perform MMSE or MMSE < 20 ;
  • Other neurodegenerative condition (Parkinson's disease, Lewy body disease, frontotemporal lobar degeneration, amyotrophic lateral sclerosis)
  • Severe anxiety or depressive disorder HADS score ≥ 17
  • Terminal phase of a severe disease
  • Evidence of a lesion on MRI that may be involved in cognitive impairment

研究组 & 干预措施

Alzheimer's Disease

Other

干预措施: Recording of smartphone usage data (Other)

Memory complaint

Other

干预措施: Recording of smartphone usage data (Other)

Mild cognitive decline

Other

干预措施: Recording of smartphone usage data (Other)

结局指标

主要结局

Comparison of a mathematical combination

时间窗: Up to three months

The comparison of a mathematical combination of the different parameters collected during the three months of smartphone data recording

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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