Identification of Graphic Markers of Neurocognitive Disorders (MG)

NCT05537688 | Completed

• 1 other identifier: 2023-1632
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Primary Progressive Aphasia; Neurocognitive Disorders

Keywords

Graphic markers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Physical and autonomy frailty

  3 months

• Socio-demographic characteristics

  3 months

• Stage of the neurodegenerative disease

  3 months

Study Arms (3)

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

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

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

Interventions

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.

Alzheimer's Disease group; Control group; PPA group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• = \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Aphasia, Primary Progressive; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior researcher, Director of laboratory

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: June 27, 2022
• Primary Completion: June 27, 2023
• Study Completion: August 27, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CA (1)