NCT05806697 Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study
| NCT ID | NCT05806697 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-04-14 |
| Primary Completion | 2030-10-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-04-14 with a primary completion date of 2030-10-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Stéphanie BOMBOIS, MD
PRINCIPAL INVESTIGATOR
Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A)
Frequently Asked Questions
Who can join the NCT05806697 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, up to 95 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05806697 currently recruiting?
Yes, NCT05806697 is actively recruiting participants. Contact the research team at nadjia.younsi@icm-institute.org for enrollment information.
Where is the NCT05806697 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05806697 clinical trial?
NCT05806697 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Stéphanie BOMBOIS, MD at Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A). The trial plans to enroll 240 participants.
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