Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study (INSIGHT-2)

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

Status

Enrolling

Conditions

Alzheimer Disease

Memory Disorders

Memory Complaint

Treatments

Radiation: 18-F amyloid PET Scan

Procedure: MRI

Procedure: Oculomotor tests

Radiation: 18F-fluorodeoxyglucose (FDG) PET Scan

Biological: Lumbar puncture

Procedure: Electroencephalogram (EEG)

Biological: Blood sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT05806697

C20-70

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

70 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects that previously participated in the INSIGHT cohort
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

Clinical Dementia Rating ≥1 at screening/baseline visit only
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).