FLORTAUCIPIR (18F) for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 60 years."}
• {"criterion_text":"- Participant in the INSPIRE-T cohort."}
• {"criterion_text":"- Normal cognitive assessment."}
• {"criterion_text":"- MMSE score ≥ 27 out of 30 (Mini-Mental State Examination)."}
• {"criterion_text":"- Normal visual abilities (in corrected or uncorrected vision)."}
• {"criterion_text":"- Normal motor skills."}
• {"criterion_text":"- Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research)."}
• {"criterion_text":"- Person affiliated to or benefiting from a social security scheme."}
• {"criterion_text":"- For participants in the ApoE4 group only: presence of the ApoE4 allele (phenotyping of ApoE protein isoforms carried out as part of the INSPIRE project)."}

Exclusion criteria

• {"criterion_text":"- Subjects with a contraindication to MRI exam"}
• {"criterion_text":"- Subjects with a known allergic reaction to the PET radiopharmaceutical ([18F] Flortaucipir) or any of its excipients"}
• {"criterion_text":"- Subjects with an ophthalmological pathology making oculometric measurements difficult (glaucoma, age-related macular degeneration, non-operated cataracts)."}
• {"criterion_text":"- Persons protected by law (adults under guardianship or safeguard of justice)."}
• {"criterion_text":"- Subjects participating in another research protocol and under exclusion delay."}
• {"criterion_text":"- Subjects with neurological or psychiatric pathology."}

Primary endpoints

• {"endpoint_text":"- diagnostic capabilities (sensitivity, specificity and AUC) of oculometry (pupillary response, number, latency and amplitude of ocular saccades), functional MRI (LC-hippocampus and LC-prefrontal cortex) and structural MRI (LC intensity) for a positive PET-Tau exam.","definition_or_measurement_approach":"Diagnostic accuracy measured by sensitivity, specificity and AUC versus a positive PET-Tau examination as reference; assessments include oculometry (pupillary response, saccade number/latency/amplitude), functional MRI (LC-hippocampus and LC-prefrontal cortex) and structural MRI (LC intensity)."}

Secondary endpoints

• {"endpoint_text":"- The diagnostic capabilities (sensitivity, specificity and AUC) of each of the elements of oculometry (pupillary response, number, latency and amplitude of ocular saccades), functional MRI (LC-hippocampus and LC-prefrontal cortex) and structural MRI (LC intensity) for a positive PET-Tau examination will be evaluated separately for the APOe4- and APOe4+ groups","definition_or_measurement_approach":"Separate diagnostic accuracy (sensitivity, specificity, AUC) analyses for APOe4- and APOe4+ strata for each oculometry, functional MRI and structural MRI element."}
• {"endpoint_text":"- The relationship between different LC biomarkers (PET, MRI, pupillometry).","definition_or_measurement_approach":"Correlation and regression analyses between PET, MRI and pupillometry LC biomarkers."}
• {"endpoint_text":"- The reliability of pupillometry and oculometry measurements will be validated by retesting a subgroup of 30 participants 1 to 4 weeks apart.","definition_or_measurement_approach":"Test-retest reliability assessed in a subgroup of 30 participants with retesting 1–4 weeks apart."}
• {"endpoint_text":"- The link between PET Tau uptake and changes at 12 and 24 months in pupillometry, oculometry and the structural (neuromelanin) and functional integrity of the LC measured on MRI will be assessed by correlating variations expressed as absolute values or as a proportion of the baseline value with PET Tau, and by regression.","definition_or_measurement_approach":"Correlation and regression analyses of baseline PET Tau with absolute and proportional changes at 12 and 24 months in pupillometry, oculometry, and MRI measures (structural and functional LC)."}
• {"endpoint_text":"- The link between variations in pupillometry, oculometry and the structural (neuromelanin) and functional integrity of the LC measured on MRI at 12 and 24 months will be evaluated by correlation between variations expressed as absolute values or as a proportion of the baseline value and by regression","definition_or_measurement_approach":"Correlation and regression analyses of changes at 12 and 24 months (absolute and proportional to baseline) across pupillometry, oculometry and MRI LC measures."}
• {"endpoint_text":"- The relationship between the various LC biomarkers (PET, MRI, pupillometry) and participants' cognitive performance will be assessed both at inclusion and at 12 and 24 months, using regressions that take into account age, gender, level of education and APOe4 status.","definition_or_measurement_approach":"Regression analyses at baseline, 12 and 24 months of LC biomarkers versus cognitive performance, adjusted for age, gender, education level and APOe4 status."}
• {"endpoint_text":"- All items will be compared between APOe4+ and APOe4- groups.a) Structural (neuromelanin) and functional integrity of the LC measured by MRI. b) Cognitive performance. c) Pupillometry and oculometry. d) And their evolution at 12 and 24 months.","definition_or_measurement_approach":"Group comparisons (APOe4+ vs APOe4-) for MRI structural/functional LC measures, cognitive performance, pupillometry/oculometry and their 12- and 24-month evolution."}

Methods

• Recruitment from the INSPIRE-T cohort (participants must be participants in the INSPIRE-T cohort).

France

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

08-11-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Fondation Vaincre Alzheimer.","duties_or_roles":"Source of monetary support","organisation_type":""}