Alzheimer DiseaseMGNCT05537688
Identification of Graphic Markers of Neurocognitive Disorders (MG)
An observational study of Alzheimer Disease and Primary Progressive Aphasia, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Primary Progressive Aphasia, Neurocognitive Disorders
- What is being tested?
- Identification of Graphic Markers
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2022to 27 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from the patient files of the principal investigator.
Who may be able to join
- = > 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Identification of Graphic Markers
- Keywords
- Graphic markers
- Medical subject headings
- Alzheimer Disease, Aphasia, Primary Progressive, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of Graphic MarkersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Identification of Graphic Markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start27 Jun 2022
- Primary completion27 Jun 2023
- Study completion27 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Olivier Beauchet, Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537688
- Sponsor's protocol ID
- 2023-1632
- Acronym
- MG
- Status last verified
- Feb 2024
- First submitted
- 8 Sep 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Graphic Markers of Neurocognitive Disorders Such as Primary Progressive Aphasia (PPA) and Early-stage Alzheimer's Disease (AD) (MG)
- ClinicalTrials.gov ID
- NCT05537688
- Acronym / sponsor ID
- MG / 2023-1632
- Keywords
- Graphic markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalOther government
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Aug 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Behavioral: Identification of Graphic MarkersParticipants 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. |
| Alzheimer's Disease group | – | Behavioral: Identification of Graphic MarkersParticipants 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. |
| PPA group | – | Behavioral: Identification of Graphic MarkersParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the patient files of the principal investigator.
Key inclusion criteria (7 listed)
- = > 50 years old
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of Graphic MarkersThe 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. | Behavioural | Alzheimer's Disease group, Control group, PPA group |
Primary outcome
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.
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.
3 secondary outcomes
Physical and autonomy frailty
Time frame: 3 months
Socio-demographic characteristics
Time frame: 3 months
Stage of the neurodegenerative disease
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Primary Progressive Aphasia, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average writing pressure (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.