Clinical trial Recruiting at 1 site Observational Ages 45 and up

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.

More Alzheimer's Disease trials

Quick facts

Study typeObservational
Ages45 Years and up
SexAll
Enrollment50000 (estimated)
SponsorFiralis SA
Industry-sponsored
Locations1 site (Huningue)
StatusRecruiting
StartedSeptember 2026
Main results expectedMay 1, 2027
Study endsMay 1, 2028
Registry record updatedSeptember 2, 2026
Trial IDNCT07679906 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.