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临床试验/NCT05537688
NCT05537688已完成不适用

Identification of Graphic Markers of Neurocognitive Disorders Such as Primary Progressive Aphasia (PPA) and Early-stage Alzheimer's Disease (AD) (MG)

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年6月27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
53
试验地点
1
主要终点
Average writing speed

研究概览

简要总结

The diagnosis of neurocognitive disorders such as early Alzheimer's disease (AD) or primary progressive aphasia (PPA) is particularly difficult and constantly evolving, often leading to diagnostic erraticity. However, several studies have shown that graphic parameters are affected in people with moderate to severe Alzheimer's disease. The use of new technologies in the study and analysis of the abilities of people with neurodegenerative diseases is increasingly recommended. The use of a digital tablet with a stylus makes it possible to objectivize the kinematic parameters of writing (pressure, inclination, speed, jerk, time of writing task) and thus would allow a low-cost diffusion of this technology in particular by including it in already existing screening batteries.

The overall objective of the project is to characterize and compare the graphical markers of a writing task, either language-based (writing words, non-words, sentences) or non-language-based (drawing shapes), in patients with PPA, early-stage Alzheimer's disease (i.e., at the stage of minor neurocognitive disorders and major neurocognitive disorders at the beginning of the disease), and in people with no cognitive disorders.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • = > 50 years old
  • For control group :
  • not have a diagnosis of minor or major neurocognitive disorder.
  • Have mild stage Alzheimer's disease: 1/ Be diagnosed according to ICD-10 criteria for the following conditions: Alzheimer's disease and 2/ Have an MMSE score between 20 and 27, corresponding to a major TNC of mild stage or have a diagnosis of minor TNC with an MMSE score between 25 and 30, the validity period of a previously done MMSE is 3 months.
  • Have Primary Progressive Aphasia according to the Gorno-Tempini criteria (Gorno-Tempini et al., 2011) and have an MMSE score between 20 and 27, corresponding to major mild TNC or have a diagnosis of minor TNC with an MMSE score between 25 and 30, the validity period of a previously made MMSE is 3 months.

排除标准

  • Presence of pathologies of the dominant upper limb(s) (left, right or ambidextrous lateralization) disabling such as osteoarthritis, finger amputation, etc.
  • History of stroke.
  • Illiterate person.
  • Participate in a concurrent experimental clinical study, to avoid interference with our study.
  • Not understand oral and written French. The speakers are French-speaking and the language task is performed in French.

结局指标

主要结局

Average writing speed

时间窗: 3 months

The second primary outcome measure is the difference in writing speed averages collected between the language and non-language tasks in the three groups of interest. It will be assessed using DTLA screening battery (Macoir et al., 2017) to which writing tasks will be added.

Average writing pressure

时间窗: 3 months

The primary outcome measure is the difference in writing pressure averages collected between the language and non-language tasks in the three groups of interest. It will be assessed using DTLA screening battery (Macoir et al., 2017) to which writing tasks will be added.

次要结局

  • Socio-demographic characteristics(3 months)
  • Stage of the neurodegenerative disease(3 months)
  • Physical and autonomy frailty(3 months)

研究者

发起方
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Olivier Beauchet

MD, PhD, Senior researcher, Director of laboratory

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

研究点 (1)

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