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:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT03129269
Eligibility Criteria:
Inclusion Criteria:
* Female and male individuals referred to the Toulouse Frailty Clinic with an objective memory impairment (CDR=0.5 or CDR=1)
* Age ≥ 70 years
* At least 1 Fried-criterion
* Informed consent signed by the patient
* Having an informant accompanying or available by phone
* Individuals affiliated to a healthcare scheme.
* \- Willing to be informed in case of a new pathology discovered through medical examination
Extension study (Cog-Frail Plus):
* COGFRAIL study participants still included in the study and completing their last visit (M 24)
* Having a family member or legal representant to sign the consent form if MMSE score \<20 at the last visit (M24)
Exclusion Criteria:
* Individuals presenting severe visual or auditory difficulties which may interfere with the completion of neuropsychological and functional assessments.
* Presence of any pathology or severe clinical or psychological condition that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
* Individuals who are robust according to the Fried criteria (0 criteria)
* Individuals who are dependent (Activities of Daily Living (ADL) \<4)
* Individuals who have a major deterioration in global cognitive function (Mini Mental State Examination (MMSE) \<20)
* Subjects deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited);
Exclusion criteria for MRI scanning :
* Claustrophobia
* Trauma or surgery which may have left ferromagnetic material in the body, including pacemakers
* History of neurosurgery or aneurism
Extension study (Cog-Frail Plus):
* Presence of any severe pathology that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
* Subjects deprived of their liberty by administrative or judicial decision, or under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT03129269
Study Brief:
Protocol Section:
NCT03129269