FLORTAUCIPIR (18F) for Alzheimer's disease|Alzheimer's pathology

Inclusion criteria

• {"criterion_text":"- Affiliation to a social security insurance or beneficiary"}
• {"criterion_text":"- Informed consent form signed by the participant or his / her legal/"}
• {"criterion_text":"- In vivo proof of Alzheimer's pathology: Determination of specific proteins on the cerebrospinal fluid (CSF, a routine care procedure)."}
• {"criterion_text":"- The values considered pathological (AD) are Aβ1-42 peptide <500 (μg / ml), and / or tau protein> 450 and phosphorylated tau protein> 60, IATI index <1, tau / Aβ protein ratios > 1.23 as well as phosphorylated tau protein / Aβ1-42> 0.211."}
• {"criterion_text":"- And / or a positive PET-amyloid imaging test."}
• {"criterion_text":"- Early-onset episodic memory deficit (<65 years), progressive onset with evidence of hippocampal amnesic syndrome at neuropsychological assessment."}
• {"criterion_text":"- In memory tests, the amnesic hippocampal syndrome is defined by: a deficit of the free recall despite a reinforced encoding, an effectiveness of the indexing or an impairment of the recognition capabilities, the presence of intrusions."}
• {"criterion_text":"- The presence during the tests of false memories spontaneous (intrusions) or provoked (false recognitions) is also very contributive to the definition of amnesic syndrome of the hippocampal type."}
• {"criterion_text":"- PCA group selection Patients with a clinical and cognitive profile suggestive of PCA, characterized by: an in vivo proof of the Alzheimer pathology (see selection of the AD-Y group) a specific impairment of neuro-visual abilities, in the absence of major disorders of episodic memory (hippocampal) and executive functions."}
• {"criterion_text":"- Two possible variants: occipito-temporal variant: visuo-perceptive deficit in the foreground, early onset and progressive worsening; lack of visual identification of objects, symbols, words or faces; biparietal variant: visuospatial deficit in the foreground, early settlement and progressive worsening; Gerstmann syndrome; Balint syndrome; gestural apraxia; visual-spatial neglect."}
• {"criterion_text":"- Selection of the control subjects group Normal neurological and neuropsychological examinations."}
• {"criterion_text":"- Control subjects will be matched in age to patients."}

Exclusion criteria

• {"criterion_text":"- Medical history of torsade de pointe or risk of torsade de pointes"}
• {"criterion_text":"- Contraindication to radiopharmaceutical injection: For precautions of safety of use of the radiopharmaceutical, a blood sample allowing to check the renal and hepatic functions will be realized before imagery."}
• {"criterion_text":"- The delay between the sampling and the neuroimaging visit is left to the investigator's discretion based on the patient's biological results."}
• {"criterion_text":"- In particular, the glomerular filtration rate will be calculated from the results obtained."}
• {"criterion_text":"- In the event of renal insufficiency (GFR 30mL / min / 1.73m2), hepatic insufficiency or any other biological anomaly of grade 3 or higher detected during these analyzes, the participant will not be able to carry out PET imaging."}
• {"criterion_text":"- In this case, the results of the analyzes will be sent to the doctor indicated by the participant."}
• {"criterion_text":"- This evaluation, which involves a determination of serum creatinine, is part of the standard routine biological assessment performed in the context of cognitive disorders"}
• {"criterion_text":"- Inability to provide informed consent by participant or legal representative:"}
• {"criterion_text":"- Patient deprived of liberty by decision of justice or not benefiting from social cover."}
• {"criterion_text":"- Person in the process of participating in another therapeutic research or in a period of exclusion from another research."}
• {"criterion_text":"- Participants with a contraindication to MRI: pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, haemostatic clips of intracerebral aneurysms or carotid arteries , carriers of orthopedic implants."}
• {"criterion_text":"- Contraindication to radiopharmaceutical injection: known hypersensitivity to the active substance or to any of the excipients, renal impairment (GFR 30mL / min / 1.73m2), hepatic insufficiency or any other biological abnormality of grade 3 or higher"}
• {"criterion_text":"- Person suffering from claustrophobia."}
• {"criterion_text":"- Pregnancy (for women of childbearing age, a urine pregnancy test will be performed on the day of the inclusion visit and the PET-MRI examination)."}
• {"criterion_text":"- Any symptoms or biological values suggestive of a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or any other medical conditions that could interfere with the interpretation of test results or compromise the health of patients."}
• {"criterion_text":"- Person subject to a legal safeguard."}
• {"criterion_text":"- Specific non-inclusion criteria for AD-Y and PCA patients: Sudden appearance of cognitive deficits."}
• {"criterion_text":"- Gait disturbances, convulsions, major behavior modification."}
• {"criterion_text":"- Focal alterations to neurological examination, extrapyramidal signs, hallucinations, fluctuations. cognitive."}
• {"criterion_text":"- Psychiatric, cerebrovascular, metabolic, inflammatory pathology."}
• {"criterion_text":"- Specific non-inclusion criteria for control subjects: Pathological neurological examination"}
• {"criterion_text":"- History of neurological disease (in particular ischemic stroke or neurodegenerative disease) or psychiatric illness (particularly severe depression, psychosis, or bipolar illness still requiring drug treatment at the time of inclusion)"}
• {"criterion_text":"- Physical affection that is serious or can interfere with cognitive functions."}

Primary endpoints

• {"endpoint_text":"- 1) The topographic distribution regions of tau lesions, thanks to PET brain imaging using the 18F-AV-1451 as a ligand.","definition_or_measurement_approach":"Measured by PET brain imaging using the 18F-AV-1451 radioligand."}
• {"endpoint_text":"- 2) The correlation between the distribution of these tau lesions and: the cortical volume, the indices of integrity of the white matter bundles, the functional neural networks, as well as the reorganization of the \"hubs\" of these networks, thanks to the structural MRI, diffusion (MRI) and functional at rest (fMRI) imaging","definition_or_measurement_approach":"Correlation analysis between tau-PET distribution and MRI-derived measures: cortical volume, white matter integrity indices (dMRI), and resting-state functional network metrics (fMRI)."}

Secondary endpoints

• {"endpoint_text":"- Correlation between the concentration of tau and tau-phosphorylated proteins in cerebrospinal fluid (CSF) with the severity of hypometabolism measured by tau-PET. To establish this correlation the evaluation criterion is represented on one side by the cortico-cerebellar indices of fixation of the tau protein radioligand in PET, on the other side by the concentration of tau proteins in the CSF and tau-phosphorylated.","definition_or_measurement_approach":"Correlation using cortico-cerebellar indices of tau radioligand fixation on PET versus concentrations of tau and phosphorylated-tau proteins in CSF."}
• {"endpoint_text":"- Correlation between anatomical and functional connectivity.","definition_or_measurement_approach":"Assessment of anatomical connectivity (dMRI) and functional connectivity (resting-state fMRI) and correlation analyses between them."}

France

Earliest CTIS Part Ii Submission Date

24-01-2025

Latest Decision Or Authorization Date

29-01-2025

Processing Time Days

5

Number Of Sites

2

Number Of Participants

45

Primary sponsor

Full Name

Institut National De La Sante Et De La Recherche Medicale

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France