NCT04240405

Brief Summary

Episodic Specificity Induction (ESI) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. But it remains to be determined 1) whether the mechanisms targeted by the ESI affect memory or executive functioning and 2) whether amnestic type (aMCI) or dysexecutive type (dMCI) mild cognitive impairment patients would benefit differently from this training, which has never been tested. By comparing the effect of the ESI on these patients, this would open up new perspectives for their symptomatic care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

4.4 years

First QC Date

January 22, 2020

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average number of internal details

    The participant sees 5 images evoking various events (e.g., a birthday, a restaurant) and describes for each one a related memory for 3 minutes. Each verbal production is recorded with a dictaphone, transcribed and then segmented into internal (episodic) or external (non-episodic) details according the coding procedure of Levine et al. (2002). The average number of internal details by autobiographical recall task is then calculated from these data.

    Day 0 (at inclusion)

Study Arms (3)

Elderly people without cognitive impairment

Amnestic type mild cognitive impairment patients (aMCI)

Dysexecutive type mild cognitive impairment patients (dMCI)

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study looks at a population of adults between the ages of 55 and 85 and 3 types of sample of subjects extracted from this population : 1. 24 elderly people without cognitive impairment 2. 24 amnestic type mild cognitive impairment patients (aMCI) 3. 24 dysexecutive type mild cognitive impairment patients (dMCI)

You may qualify if:

  • The participant:
  • has provided informed consent obtained in accordance with Good Clinical Practices.
  • is affiliated to a social security system.
  • speaks fluent French.
  • is between 55 and 85 years of age.
  • For the participants of the control group:
  • has a Montreal Cognitive Assessment (MoCA) score equal to or greater than 26;
  • has neuropsychological assessment performance (RL/RI 16, D080, TMT, VOSP, Rey's figure) in the norm according to his socio-professional category and age, i.e. less than two deviating scores of -1 standard deviation or less than the 10th percentile per function.
  • For patients in the TCLa group:
  • has at least two scores below the 10th percentile or below -1 standard deviation from the norm on neuropsychological assessment tests that assess memory, based on its socio-professional category and age;
  • has less than two scores below the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess other functions. This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).
  • For patients in the TCLd group:
  • has focal executive dysfunction expressed by at least two scores less than the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess executive functions (TMT, Stroop, verbal fluences, free recall in memory), according to his socio-professional category and age;
  • has less than two scores below the 10th percentile or less than -1 standard deviation from the norm on neuropsychological assessment tests that assess other functions (except for free memory reminders and language fluences). This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).

You may not qualify if:

  • The participant:
  • meets the criteria for a major neurocognitive disorder of the DSM-5.
  • has a neurological disorder of infectious origin.
  • has a psychiatric illness.
  • has a severe uncompensated sensory deficit.
  • is a substance abuser.
  • has had chronic depression or anxiety that has not stabilized for 3 months.
  • refuses to participate.
  • is participating in another intervention research project.
  • is placed under the protection of justice.
  • refuses to sign the consent form.
  • is unable to express its consent.
  • consumed toxic substances or alcohol at the time of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratoire d'Étude des Mécanismes Cognitifs

Bron, 69676, France

Location

Centre Mémoire Ressources Recherche de Lyon, Institut du Vieillissement, Hôpital des Charpennes

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

December 11, 2019

Primary Completion

April 19, 2024

Study Completion

April 19, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations