240
Participants
Start Date
April 14, 2023
Primary Completion Date
October 9, 2030
Study Completion Date
October 9, 2030
Electroencephalogram (EEG)
The EEG will be uniquely performed during for the whole study if a given subject converts to symptomatic AD or in the occurrence of significant cognitive decline.
Oculomotor tests
All participants in the INSIGHT-2 study are invited to perform the oculomotor test, excepting subjects reporting oculomotor disorders.
MRI
All INSIGHT-2 participants will undergo a baseline MRI (structural and resting state fMRI) a follow-up MRI at M12, M36 and M60.
18-F amyloid PET Scan
The primary endpoint is conversion to the symptomatic stage in subjects at risk, identified by positive amyloid staining (A+) on florbetapir PET imaging. Participants will receive an injection of 18F-Florbetapir prior to undergoing amyloid PET scanning. Florbetapir (18F) is an experimental imaging compound labeled with \[18F\] fluorine that decays by positron (β+) emission and has a half-life of 109.77 min. This procedure will be done at baseline.
18F-fluorodeoxyglucose (FDG) PET Scan
Participants will receive an injection of Fludeoxyglucose 18F prior to undergoing FDG-PET. The \[18F\]FDG is the most well-known radiopharmaceutical positron emitter, in both clinical and preclinical fields.
Blood sampling
A total of 80 ml of whole blood will be collected for each participant in the INSIGHT-2 study for routine laboratory assessment and biobank sampling.
Lumbar puncture
A lumbar puncture for cerebrospinal fluid (CSF) collection is proposed to all participants.
RECRUITING
Hôpital Pitié Salpêtrière, Paris
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV