ALZEVIT: Nationwide Digital APOE ε4 Cohort for Early Alzheimer's Disease Prevention and Trial Readiness

Summary

ALZEVIT is a nationwide, decentralized, digital-first cohort study in France designed to establish a large-scale Apolipoprotein E (APOE) genotyping registry and enable precision prevention strategies for Alzheimer's disease (AD). Sponsored by Firalis SA and conducted in collaboration with French memory centers, it addresses the need for early identification of individuals at high genetic risk, particularly APOE ε4 carriers and ε4/ε4 homozygotes, in the context of emerging disease-modifying therapies most effective in preclinical or early disease stages. Using an online recruitment platform, participants aged ≥45 years provide electronic informed consent and self-collected saliva samples via home collection kits for centralized APOE genotyping using the APO-Easy® assay, compliant with EU IVDR and US FDA requirements. Data are stored in a secure registry compliant with GDPR. Phase A (0-18 months) will enroll 50,000 participants to determine national APOE genotype distribution, identify high-risk individuals, and evaluate feasibility of large-scale digital genetic screening, with longitudinal online follow-up including cognitive and risk factor assessments. Phase B (12-24 months) includes detailed phenotyping of \~2,350 selected participants across all APOE genotypes, including \~750 ε4/ε4 homozygotes. Participants undergo clinical evaluation, MRI, cognitive testing, and multi-omics biomarker profiling (genomics, proteomics, metabolomics, environmental exposure), conducted at memory centers or via telemedicine. The study classifies participants along the cognitive continuum, including cognitively normal individuals, preclinical AD, mild cognitive impairment (MCI), and mild or moderate AD, to identify genotype-specific trajectories and modifiable risk and resilience factors. ALZEVIT aims to establish a scalable national infrastructure linking genetic stratification with longitudinal biomarker and clinical data to support prevention trials, improve understanding of APOE-related heterogeneity, and advance precision medicine for Alzheimer's disease.

Eligibility

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.

Conditions2

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