APOE Genotype Registry for Alzheimer's Prevention in France
Official title: ALZEVIT: A Nationwide Decentralized Digital Cohort for Population APOE Genotyping, Longitudinal Characterization of APOE ε4/ε4 Trajectories, and Trial-readiness for Precision Prevention in Early Alzheimer's Disease
Run by Firalis SA · NCT07679906 · Data updated 2026-11-12
This nationwide, digital-first effort tests a large APOE genotyping registry in adults 45 and older in France to help prepare for prevention trials and future therapies for Alzheimer's disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 50000 (estimated) |
| Sponsor | Firalis SA Industry-sponsored |
| Locations | 1 site (Huningue) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07679906 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 45 years and over who live in France, can read French, have internet access, and can perform at-home saliva collection for APOE testing.
✕Probably not a fit
Participants who are not at elevated genetic risk or who do not pursue future prevention trials may not experience direct benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ALZEVIT is a decentralized, digital-first observational cohort in France that aims to build a large APOE genotyping registry and a trial-ready infrastructure for precision prevention of Alzheimer's disease. Participants provide electronic consent and self-collect saliva samples at home for centralized APOE genotyping, with data stored in a GDPR-compliant registry. The first phase plans to enroll 50,000 individuals aged 45+ to map APOE genotype distribution and enable risk stratification for targeted prevention efforts in the context of emerging disease-modifying therapies. The study integrates digital tools, centralized genetics, and longitudinal phenotyping across French memory centers to identify high-risk individuals, particularly APOE ε4 carriers and ε4/ε4 homozygotes, for future prevention trials. Interventions are not part of this observational phase, but the infrastructure supports future trial readiness.
Why it matters
Potential benefit: If successful, the study could enable faster identification of people at genetic risk for Alzheimer's and improve enrollment for prevention trials.
How similar studies have gone: Previous genetic stratification efforts in other populations have shown value in trial readiness, though this exact large-scale APOE registry in France is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who sign the electronic Informed Consent form. * Adults aged over 45 years old (inclusive) at the time of consent. * Participants residing in France. * Participants able to read and understand the study information in French or with the help of a legal representative. * Participants are capable of electronically signing the consent form. * Participants affiliated with the French national health insurance system. * Participants with access to the internet and a valid email address. * Participants can self-collect and return a saliva sample using a provided kit (ORAcollect® Dx device). Exclusion Criteria: * Participants who do not sign the Informed Consent form. * Participants who are unable to read or understand French. * Participants younger than 45 years at the time of consent. * Participants with known cognitive impairments, severe dementia, or psychiatric conditions that prevent informed consent. * Participants with a documented substance use disorder (alcohol or drug dependence) within the past 24 months. * Participants who cannot be reliably contacted by email or phone. * Participants previously enrolled in the ALZEVIT study or its pilot phase. * Participants who are legally protected adults or under guardianship, curatorship, or judicial/administrative custody. * Participants whose physical condition does not allow them to perform the tasks required by the study. * Participants who, in the judgment of the Investigator, are unlikely to comply with study procedures. * Participants who are study staff (investigators, sub-investigators, coordinators, assistants) or their immediate family members. * Participants who are incarcerated or deprived of liberty by judicial or administrative decision. * Participants with any disease or condition that, in the opinion of the Investigator, would compromise participation or safety.
Where it's running
-
FIRALIS SA - Centre de Prélèvements Biologiques
Huningue, France Recruiting
Study contacts
- Principal investigator: Audrey GABELLE,, MD, PhD — CMRR Languedoc-Roussillon - Montpellier
- Study coordinator: Hüseyin FIRAT, MD, PhD, HDR
- Email: hueseyin.firat@firalis.com
- Phone: +33 (0) 389 911 321
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.