NCT05668598

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2026

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

December 9, 2022

Last Update Submit

January 2, 2026

Conditions

Keywords

GERIATRICS

Outcome Measures

Primary Outcomes (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).

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

    day 1

Secondary Outcomes (3)

  • To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.

    day 1

  • To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.

    day 1

  • To compare between case and control the various dimensions of episodic memory: temporal component, space component and association component.

    day 1

Study Arms (2)

Groupe 1 : with neurocognitive disorders

OTHER

with neurocognitive disorders

Diagnostic Test: ecological MAI test

Groupe 2 : without neurocognitive disorders

OTHER

without neurocognitive disorders

Diagnostic Test: ecological MAI test

Interventions

ecological MAI testDIAGNOSTIC_TEST

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

Groupe 1 : with neurocognitive disordersGroupe 2 : without neurocognitive disorders

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospiralier de Lens

Lens, 62408, France

RECRUITING

MeSH Terms

Conditions

Memory DisordersNeurocognitive Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Brunhilde CANESSON

CONTACT

Mélanie VERLAY

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Interventional, prospective, Study case-control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 30, 2022

Study Start

March 8, 2023

Primary Completion

March 8, 2026

Study Completion

March 9, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations