- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05668598
Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics (ECOTESTGER)
Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics: an Adaptation of the Memory Test With Self-Initiated Items (MAI)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brunhilde CANESSON
- Phone Number: +33 03.21.69.16.36
- Email: bcanesson@ch-lens.fr
Study Contact Backup
- Name: Mélanie VERLAY
- Phone Number: +33 03.21.69.10.28
- Email: mverlay@ch-lens.fr
Study Locations
-
-
-
Lens, France, 62408
- Recruiting
- Centre Hospiralier de Lens
-
Contact:
- MELANIE VERLAY
- Phone Number: 0601023068
- Email: mverlay@ch-lens.fr
-
Principal Investigator:
- BRUNHILDE CANESSON
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Groupe 1 : with neurocognitive disorders
with neurocognitive disorders
|
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
|
Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease. Study test is ecological MAI. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
Time Frame: day 1
|
Overall score remind ecological MAI test (0 to 12) in two groups.
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.
Time Frame: day 1
|
Spatial component is defined by localisation score.
Score (0 to 12)
|
day 1
|
|
To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.
Time Frame: day 1
|
Temporal component is defined by temporal dimension. Score (0 to 12) |
day 1
|
|
To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.
Time Frame: day 1
|
Association component is defined by binding score. Score (0 to 12) |
day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-02
- 2022-A02139-34 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.