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Clinical Trials/NCT05537688
NCT05537688
Completed
Not Applicable

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 site in 1 country53 target enrollmentJune 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Enrollment
53
Locations
1
Primary Endpoint
Average writing speed
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 27, 2022
End Date
August 27, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

  • = \> 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Average writing speed

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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