Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
NCT ID: NCT05806697
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2023-04-14
2030-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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All participants
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Aged 70 to 95 years old
* Having signed an informed consent
* Willing to and able undergo a baseline PET amyloid imaging
* Affiliating to the French health-care system
* Having an identified informant who has sufficient contact with the participant and has to be able to provide accurate information, at least by phone, about the participants' cognitive and functional abilities.
Exclusion Criteria
* Fulfilling research diagnostic criteria for any type of dementia-related disorder at screening visit (clinical AD, Dementia with Lewy Bodies \[DLB\], fronto-temporal dementia \[FTD\], vascular dementia, chronic traumatic encephalopathy \[CTE\], Limbic-predominant Age-related TDP-43 Encephalopathy \[LATE\], Primary age-related tauopathy \[PART)
* Presence of any medical condition associated with a long-term risk of cognitive impairment or dementia including Parkinson's disease, brain tumor, subdural hematoma, vascular malformations, territorial stroke (excluding smaller watershed strokes), chronic hydrocephalus, traumatic brain injury with neurological sequelae, active alcohol/drug abuse, major depressive disorder, schizophrenia and bipolar disorder
* Current serious or unstable illnesses (including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic or hematologic disease) that might make the subject's participation in an investigational trial unsafe
* Any contraindications for MRI/ PET scan procedure (claustrophobia, ferromagnetic object in the body), to FDG or to 18F-Florbetapir (Amyvid®).
* Hypersensitivity to the active substance or to any of the excipients of 18F-Florbetapir (Amyvid®).
* Participation in any clinical trial of an investigational product in the last 30 days before the screening (during all study duration co-inclusion in other clinical trial of an investigational product or observational research \[biomarker cohort e.g.\] will be possible but the information would need to be recorded).
* Unable to comply with protocol requirements in the opinion of the investigator
* Being under guardianship (safeguard of justice, curatorship or guardianship)
* Residence in skilled nursing facility, including nursing homes (EHPAD).
70 Years
95 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Stéphanie BOMBOIS, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A)
Locations
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Hôpital Pitié Salpêtrière
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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C20-70
Identifier Type: -
Identifier Source: org_study_id
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