Identification of Graphic Markers of Neurocognitive Disorders (MG) (MG)

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

Study Overview

• Status: Completed
• Conditions: Neurocognitive Disorders; Alzheimer Disease; Primary Progressive Aphasia
• Intervention / Treatment: Behavioral: Identification of Graphic Markers

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3W 1W5
      • CRIUGM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from the patient files of the principal investigator.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Participants will complete a graphic task included in a validated test for language impairment in adults and the elderly (DTLA). They must not have a diagnosis of minor or major neurocognitive disorder.	Behavioral: Identification of Graphic Markers; 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.
Alzheimer's Disease group; Participants will complete a graphic task included in a validated test for language impairment in adults and the elderly (DTLA). They must 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.	Behavioral: Identification of Graphic Markers; 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.
PPA group; Participants will complete a graphic task included in a validated test for language impairment in adults and the elderly (DTLA). They must 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 mild stage major CND or have a diagnosis of minor CND with an MMSE score between 25 and 30, the validity period of a previously made MMSE is 3 months.	Behavioral: Identification of Graphic Markers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average writing pressure	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.	3 months
Average writing speed	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical and autonomy frailty	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.	3 months
Socio-demographic characteristics	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 months
Stage of the neurodegenerative disease	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.	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): August 27, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Graphic markers
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Alzheimer Disease; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Neurocognitive Disorders
• Other Study ID Numbers: 2023-1632

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No