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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalogram (EEG) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | every year through study completion, from baseline for 5 years (M60) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Dementia Rating- Sum of Boxes (CDR-SB) score compared to baseline | CDR-SB : Hughes, Br J Psychiatry 1982; 140: 566-72 | Each 1 year from baseline for 5 years (M60) |
| Change in different neuroimaging, biological, electrophysiological and oculomotor parameters compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadjia YOUNSI | Contact | +331 42 16 75 15 | nadjia.younsi@icm-institute.org |
| Name | Affiliation | Role |
|---|---|---|
| Stéphanie BOMBOIS, MD | Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié Salpêtrière | Recruiting | Paris | Île-de-France Region | 75013 | France |
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| Oculomotor tests | Procedure | All participants in the INSIGHT-2 study are invited to perform the oculomotor test, excepting subjects reporting oculomotor disorders. |
|
| MRI | Procedure | 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 | Radiation | 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 | Radiation | 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 | Biological | 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 | Biological | A lumbar puncture for cerebrospinal fluid (CSF) collection is proposed to all participants. |
|
Exploratory outcomes |
| 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 | 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 | Each 1 year from baseline for 5 years (M60) |
| Conversion to symptomatic non-AD cognitive disease | Atypical AD according to IWG 2014 criteria | 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 | Each 1 year from baseline for 5 years (M60) |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| D001800 | Blood Specimen Collection |
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D001706 | Biopsy |
| D003943 | Diagnostic Techniques, Neurological |
| D013812 | Therapeutics |
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