Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study

NARecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

April 14, 2023

Primary Completion Date

October 9, 2030

Study Completion Date

October 9, 2030

Conditions
Alzheimer DiseaseMemory ComplaintMemory Disorders
Interventions
PROCEDURE

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.

PROCEDURE

Oculomotor tests

All participants in the INSIGHT-2 study are invited to perform the oculomotor test, excepting subjects reporting oculomotor disorders.

PROCEDURE

MRI

All INSIGHT-2 participants will undergo a baseline MRI (structural and resting state fMRI) a follow-up MRI at M12, M36 and M60.

RADIATION

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.

RADIATION

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.

BIOLOGICAL

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.

BIOLOGICAL

Lumbar puncture

A lumbar puncture for cerebrospinal fluid (CSF) collection is proposed to all participants.

Trial Locations (1)

75013

RECRUITING

Hôpital Pitié Salpêtrière, Paris

All Listed Sponsors
lead

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV