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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05668598
Other study ID # 2022-02
Secondary ID 2022-A02139-34
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2023
Est. completion date December 2025

Study information

Verified date June 2024
Source Centre Hospitalier de Lens
Contact Brunhilde CANESSON
Phone 03.21.69.16.36
Email bcanesson@ch-lens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study the participants can be recruited via scheduled consultation and external institutions (associations, senior club..). Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease. Study test is ecological MAI. This test are assigned in two groups (with or without neurocognitive disorders).


Description:

In this study the participants can be recruited via scheduled consultation and external institutions (associations, senior club..). Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease. Study test is ecological MAI. Participation will be 30 minutes for patients see in case of routine care and 2h30 for those accompanying the patients and participants recruited in external institutions. Participants are assigned in two groups. Group 1 : with neurocognitive disorders Group 2 : without neurocognitive disorders Benefits : For participants without neurodegenerative disorder, study enables to take control early if anomaly will be detected. The study permit to have cognitive assessment. Risk : It's possible that participants feel tired. No constraints for participants seen during scheduled consultation.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - Male or female = 70 ans - Person have good locomotion, move independently - Personne agree to participate Groupe 1 : 17=MMSE=24 (GRECO) Diagnosis of neurodegenerative diseases (major neurocognitive disorders: Alzheimer, mixed dementia, lobar frontotemporal degeneration, vascular dementia). Groupe 2 : MMSE = à 25 (GRECO) Without neurodegenerative disease Exclusion Criteria: - Person with legal protective measures - Person deprived of liberty - Mental retardation or MMSE= 16 - Understanding verbal disorders - Visual major disturbances - Person with disease causing increased fatigue - Person with psychiatric pathology excepted anxiety disorder or depression with mild episodes. - Person not covered by French national health insurance

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ecological MAI test
Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease. Study test is ecological MAI.

Locations

Country Name City State
France Centre Hospiralier de Lens Lens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier de Lens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare performance obtaining to overall score remind ecological MAI between older persons with neurocognitive disorders (groupe 1) and older persons without neurocognitive disorders (groupe 2). Overall score remind ecological MAI test (0 to 12) in two groups. day 1
Secondary To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component. Spatial component is defined by localisation score. Score (0 to 12) day 1
Secondary To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component. Temporal component is defined by temporal dimension.
Score (0 to 12)
day 1
Secondary To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component. Association component is defined by binding score.
Score (0 to 12)
day 1
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