2-(6-[18F]FLUORO-PYRIDIN-3-YL)-9H-DIPYRIDO[2,3-B:3',4'-D]PYRROLE for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- General inclusion criteria: Adult (men or women), Women old enough to procreate under effective contraception, signed consent, for the patients absence of general or systemic disorders that may interfere with cognition."}
• {"criterion_text":"- IFor the controls: absence of subjective problems with memory and normal scores on the MMSE (MMSE > 27) with no more than one word missing, older than 50 years old, scores on the Free and Cued Selective Reminding Test (FCSRT) of >25 for free recall and >44 for total recall, absence of general or systemic disorders that may interfere with cognition at follow-up."}
• {"criterion_text":"- For patients with Alzheimer’s Disease at the early stage: AD patients will be defined as EOAD or LOAD according to the age of the onset of the disease as EOAD: onset of the disease ≤ 65 years and LOAD: onset of the disease > 65 years."}
• {"criterion_text":"- Progressive amnestic syndrome, associated or not with other cognitive impairments or predominant parietal cognitive, CDR = 0.5 or 1 syndrome (parietal phenotype of AD) for EOAD,"}
• {"criterion_text":"- Absence of general or systemic disorders that may interfere with cognition or PET imaging analysis,"}
• {"criterion_text":"- Absence of brain lesions as determined by MRI carried out within the framework of usual care."}
• {"criterion_text":"- Presence of CSF biomarkers profile suggestive of AD"}

Exclusion criteria

• {"criterion_text":"- Subject with a psychiatric evolutionary and/or badly checked pathology (left to the judgement of the investigator)."}
• {"criterion_text":"- Subject with a grave, severe or unstable pathology (left to the judgement of the investigator) the nature of which can interfere with the variables of evaluation."}
• {"criterion_text":"- Current auto-immune disease, subject presenting contraindications to the 3T MRI"}
• {"criterion_text":"- Known or supposed histories (≤5 years) of severe alcoholism or misuse of drugs"}
• {"criterion_text":"- Vascular, inflammatory or expansive, visible lesion in the MRI which can interfere on the criteria of diagnosis."}
• {"criterion_text":"- No health insurance, pregnant, breast-feeding woman or planning a pregnancy in two years of follow-up."}
• {"criterion_text":"- Diagnosis or history of other possible etiology of dementia, including but not limited to other neurodegenerative disorders."}
• {"criterion_text":"- Person placed under the protection of justice, patient under guardianship or curatorship"}

Primary endpoints

• {"endpoint_text":"- The degree of correlation at baseline between [18F]-DPA-714, [18F]-Ro948, and [11C]-UCB-J expressed in SUVr will be assessed with Kendall's Tau test","definition_or_measurement_approach":"Correlation at baseline between PET tracers expressed in SUVr; association assessed using Kendall's Tau test."}

Secondary endpoints

• {"endpoint_text":"- The multivariate approach of the Mixed Model Repeated Measures (MMRM) will be used to evaluate the longitudinal evolution of clinical and instrumental parameters collected. Analyses will be adjusted for clinical and demographic characteristics at baseline.","definition_or_measurement_approach":"Longitudinal evolution assessed using a Mixed Model Repeated Measures (MMRM) multivariate approach, with analyses adjusted for baseline clinical and demographic characteristics."}

France

Earliest CTIS Part Ii Submission Date

15-10-2024

Latest Decision Or Authorization Date

15-10-2025

Processing Time Days

365

Number Of Sites

3

Number Of Participants

90

Primary sponsor

Full Name

Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Cofinancement institut Roche et ANR (Agence Nationale pour la Recherche)","duties_or_roles":"Monetary support / co-funder","organisation_type":""}