Identification of Graphic Markers of Neurocognitive Disorders (MG)

Alzheimer Disease Clinical Trial

— MG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05537688
• Other study ID #: 2023-1632
• Status: Completed
• Start date: June 27, 2022
• Est. completion date: August 27, 2023

Study information

• Verified date: February 2024
• Source: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Neurocognitive Disorders
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

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.

Locations

Country	Name	City	State
Canada	CRIUGM	Montréal	Quebec

Sponsors (1)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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