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.

Conditions

• Alzheimer

Sponsors & Collaborators

• CHU de Reims

  collaborator OTHER

• University Hospital, Marseille

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• University Hospital, Strasbourg, France

  collaborator OTHER

• Centre Hospitalier de Colmar

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Firalis SA

  lead INDUSTRY

Principal Investigators

• Audrey GABELLE,, MD, PhD · CMRR Languedoc-Roussillon - Montpellier

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2027-05-01

Completion

2028-05-01

Countries

• France

Study Locations