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ECOTESTGER: Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics

Sponsor
Centre Hospitalier de Lens (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05668598
Collaborator
(none)
60
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ecological MAI test
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Interventional, prospective, Study case-controlInterventional, prospective, Study case-control
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics: an Adaptation of the Memory Test With Self-Initiated Items (MAI)
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Groupe 1 : with neurocognitive disorders

with neurocognitive disorders

Diagnostic Test: ecological MAI test
Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease. Study test is ecological MAI.
Other: Groupe 2 : without neurocognitive disorders

without neurocognitive disorders

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

Outcome Measures

Primary Outcome Measures

  1. 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). [day 1]

    Overall score remind ecological MAI test (0 to 12) in two groups.

Secondary Outcome Measures

  1. To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component. [day 1]

    Spatial component is defined by localisation score. Score (0 to 12)

  2. To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component. [day 1]

    Temporal component is defined by temporal dimension. Score (0 to 12)

  3. To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component. [day 1]

    Association component is defined by binding score. Score (0 to 12)

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier de Lens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier de Lens
ClinicalTrials.gov Identifier:
NCT05668598
Other Study ID Numbers:
  • 2022-02
  • 2022-A02139-34
First Posted:
Dec 30, 2022
Last Update Posted:
Dec 30, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier de Lens
GERIATRICS
Additional relevant MeSH terms:
Memory Disorders
Disease
Neurocognitive Disorders

Study Results

No Results Posted as of Dec 30, 2022