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NCT Number: NCT05537688

Identification of Graphic Markers of Neurocognitive Disorders (MG)

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.

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Key information

Conditions

Alzheimer Disease Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Progressive Aphasia Signs and Symptoms Speech Disorders Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • = > 50 years old

For control group :

  • not have a diagnosis of minor or major neurocognitive disorder.

For AD :

  • 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.

For PPA :

  • 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.

Treatment and study plan

Identification of Graphic Markers

Behavioral

The study consists of a single physical visit to the research team's site.

Participants will take a graphic task included in a validated test for language impairment in adults and older adults (DTLA). This test with writing data has a maximum completion time of 15 minutes. Diagnostic data will be collected from the patient's chart, frailty data and socio-demographic data will be collected by self-questionnaires.

Participants will be evaluated by the principal investigator or his or her representatives from the research team.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Physical and autonomy frailty

    Time frame: 3 months

    A physical frailty score will be obtained by using the CARE questionnaire. An autonomy frailty score will be obtained by using ADL and IADL scales.

  2. Socio-demographic characteristics

    Time frame: 3 months

    Participants will be asked their date of birth, sex, gender, lateralization (right-handed, left-handed or ambidextrous), level of education, born in Canada or elsewhere, number of years on Canadian soil, place of living (individual residence, RPP, other), presence of a natural caregiver.

  3. Stage of the neurodegenerative disease

    Time frame: 3 months

    Stage of the neurodegenerative disease will be assessed by using the MMSE test.

    Furthermore, participants will be asked the number of medications taken per day, the use of psychotropic medications (antidepressants, anxiolytics, neuroleptics) and the use of an antidementia treatment.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: MG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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