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Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics (ECOTESTGER)

Primary Purpose

Memory Disorders, Neurocognitive Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ecological MAI test
Sponsored by
Centre Hospitalier de Lens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Memory Disorders focused on measuring GERIATRICS

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospiralier de LensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Groupe 1 : with neurocognitive disorders

Groupe 2 : without neurocognitive disorders

Arm Description

with neurocognitive disorders

without neurocognitive disorders

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
December 9, 2022
Last Updated
March 23, 2023
Sponsor
Centre Hospitalier de Lens
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1. Study Identification

Unique Protocol Identification Number
NCT05668598
Brief Title
Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics
Acronym
ECOTESTGER
Official Title
Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics: an Adaptation of the Memory Test With Self-Initiated Items (MAI)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Lens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders, Neurocognitive Disorders
Keywords
GERIATRICS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional, prospective, Study case-control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Groupe 1 : with neurocognitive disorders
Arm Type
Other
Arm Description
with neurocognitive disorders
Arm Title
Groupe 2 : without neurocognitive disorders
Arm Type
Other
Arm Description
without neurocognitive disorders
Intervention Type
Diagnostic Test
Intervention Name(s)
ecological MAI test
Intervention Description
Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease. Study test is ecological MAI.
Primary Outcome Measure Information:
Title
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).
Description
Overall score remind ecological MAI test (0 to 12) in two groups.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.
Description
Spatial component is defined by localisation score. Score (0 to 12)
Time Frame
day 1
Title
To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.
Description
Temporal component is defined by temporal dimension. Score (0 to 12)
Time Frame
day 1
Title
To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.
Description
Association component is defined by binding score. Score (0 to 12)
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brunhilde CANESSON
Phone
03.21.69.16.36
Ext
+33
Email
bcanesson@ch-lens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie VERLAY
Phone
03.21.69.10.28
Ext
+33
Email
mverlay@ch-lens.fr
Facility Information:
Facility Name
Centre Hospiralier de Lens
City
Lens
ZIP/Postal Code
62408
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MELANIE VERLAY
Phone
0601023068
Email
mverlay@ch-lens.fr
First Name & Middle Initial & Last Name & Degree
BRUNHILDE CANESSON

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics

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