NCT03129269 · ACTIVE NOT RECRUITING
Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
This study uses MRI and PET scans to measure how common amyloid plaques are in frail older adults who have some memory problems. Researchers in Toulouse, France then follow these patients over time to compare how those with Alzheimer's-related amyloid pathology progress versus those who do not. This is a Phase NA observational study, meaning researchers are watching and measuring, not testing a treatment.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-02-12