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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

A regional, single-center, prospective, observational academic cohort will follow subjects who previously participated in the INSIGHT study and who agree an extension of their follow-up in the INSIGHT-2 research for additional 5-6 years. An annual multimodal evaluation (cognitive, oculomotor, biological and neuroimaging) will be proposed in order to describe the natural history of preclinical Alzheimer's disease (AD). The primary endpoint is the conversion to the symptomatic stage in subjects at risk, identified by positive amyloid staining (A+) on florbetapir positron emission tomography (PET) imaging. The size of the cohort is estimated to around 240 participants (61 A+ subjects) among the 318 participants included in the main cohort (88 A+ subjects). The follow-up in the INSIGHT-2 cohort will be lightened compared to that of the main cohort with an annual frequency of visits rather than a six-monthly one.

Eligibility

Primary outcome measure(s)

• The primary endpoint is the conversion to typical AD during the 5-year follow-up. — every year through study completion, from baseline for 5 years (M60)
  Typical AD according to International Working Group (IWG) 2014 criteria = amyloid-positive participants, with an abnormal decline of episodic memory performance on the Free and Cued Selective Reminding Test

Trial sites (1)

More Institut National de la Santé Et de la Recherche Médicale, France trials in France

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