Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT04240405
Eligibility Criteria:
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT04240405
Study Brief:
Protocol Section:
NCT04240405