An interventional study of Electroencephalogram (EEG) and Oculomotor tests in Alzheimer Disease, Memory Complaint and Memory Disorders, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Recruiting at 1 site in France. Open to participants aged 70 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Other
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 240 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Investigational drug or device
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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Procedure: Electroencephalogram (EEG) · Procedure: Oculomotor tests · Procedure: MRI · Radiation: 18-F amyloid PET Scan · Radiation: 18F-fluorodeoxyglucose (FDG) PET Scan · Biological: Blood sampling · Biological: Lumbar puncture
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.
All participants in the INSIGHT-2 study are invited to perform the oculomotor test, excepting subjects reporting oculomotor disorders.
All INSIGHT-2 participants will undergo a baseline MRI (structural and resting state fMRI) a follow-up MRI at M12, M36 and M60.
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.
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.
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.
A lumbar puncture for cerebrospinal fluid (CSF) collection is proposed to all participants.
The primary endpoint is the conversion to typical AD during the 5-year follow-up.
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
Time frame: every year through study completion, from baseline for 5 years (M60)
Change in Clinical Dementia Rating- Sum of Boxes (CDR-SB) score compared to baseline
CDR-SB : Hughes, Br J Psychiatry 1982; 140: 566-72
Time frame: Each 1 year from baseline for 5 years (M60)
Change in different neuroimaging, biological, electrophysiological and oculomotor parameters compared to baseline
Exploratory outcomes
Time frame: Each 1 year from baseline for 5 years (M60)
Change of the score in different self-administered, informant based questionnaires (including the Quality Of Life (QOL), Ascertain Dementia 8 (AD)8 Dementia Screening Interview, Aging Brain Care Monitor)
Exploratory outcomes
Time frame: Each 1 year from baseline for 5 years (M60)
Rate of change in biomarkers measured from blood, CSF, structural and functional neuroimaging (MRI), EEG and molecular neuroimaging (18F-FDG-PET and amyloid imaging)
Exploratory outcomes
Time frame: Each 1 year from baseline for 5 years (M60)
Conversion to symptomatic non-AD cognitive disease
Atypical AD according to IWG 2014 criteria
Time frame: Each 1 year from baseline for 5 years (M60)
Diagnosis of cerebral amyloid angiopathy based on V2.0 BOSTON criteria
As described in the following reference: Charidimou et al., Lancet Neurol. 2022 Aug;21(8):714-725
Time frame: Each 1 year from baseline for 5 years (M60)
Plan to share: No
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