ALZEVIT: Nationwide Digital APOE ε4 Cohort for Early Alzheimer's Disease Prevention and Trial Readiness
ConditionAlzheimer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorFiralis SA
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Phase A: ALZEVIT will enroll 50,000 French adults aged ≥45 years, stratified across five age groups. Participants will complete online risk-factor and cognitive assessments and provide a home-collected saliva sample for APOE genotyping. The study is expected to identify approximately 750 APOE ε4/ε4 homozygotes and establish a secure, GDPR-compliant national APOE registry. Phase B: A subset of 2,350 participants representing all six APOE genotypes, including 750 ε4/ε4 homozygotes, will undergo detailed clinical, cognitive, MRI, and biomarker evaluations. The objective is to characterize genotype-specific trajectories and classify participants according to Alzheimer's disease stage, from cognitively normal to preclinical AD, MCI-AD, and mild/moderate AD.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
50,000 Participants
are grouped into 30 trial groups30
Trial groupsSee each trial group below.
Group A: ε2/ε2 (45-54)
Group B: ε2/ε2 (55-64)
Group C: ε2/ε2 (65-74)
Group D: ε2/ε2 (75-84)
Group E: ε2/ε2 (≥85)
Group F: ε2/ε3 (45-54)
Group G: ε2/ε3 (55-64)
Group H: ε2/ε3 (65-74)
Group I: ε2/ε3 (75-84)
Group J: ε2/ε3 (≥85)
Group K: ε2/ε4 (45-54)
Group L: ε2/ε4 (55-64)
Group M: ε2/ε4 (65-74)
Group N: ε2/ε4 (75-84)
Group O: ε2/ε4 (≥85)
Group P: ε3/ε4 (45-54)
Group Q: ε3/ε4 (55-64)
Group R: ε3/ε4 (65-74)
Group S: ε3/ε4 (75-84)
Group T: ε3/ε4 (≥85)
Group U: ε3/ε3 (45-54)
Group V: ε3/ε3 (55-64)
Group W: ε3/ε3 (65-74)
Group X: ε3/ε3 (75-84)
Group Y: ε3/ε3 (≥85)
Group Z: ε4/ε4 (45-54)
Group [: ε4/ε4 (55-64)
Group \: ε4/ε4 (65-74)
Group ]: ε4/ε4 (75-84)
Group ^: ε4/ε4 (≥85)
Trial outcomes
Primary outcomes
1
1. APOE genotype distribution in the study population
Proportion and frequency of APOE genotypes (ε2/ε2, ε2/ε3, ε2/ε4, ε3/ε3, ε3/ε4, ε4/ε4) in adults aged ≥45 years in France, stratified by age group.
Time frame
through study completion, an average of 2 years2
2. Feasibility of large-scale decentralized APOE genotyping registry
Operational performance of the digital-first model, including rates of electronic consent completion, home saliva kit return, DNA sample adequacy, and successful centralized APOE genoty
Time frame
through study completion, an average of 2 years3
3. Identification of APOE ε4/ε4 homozygotes in the national cohort
Number and proportion of ε4/ε4 individuals identified across age strata and successfully enrolled in the registry.
Time frame
through study completion, an average of 2 years4
4. Establishment of a secure longitudinal APOE registry
Creation of a GDPR-compliant database enabling longitudinal follow-up of participants with APOE genotype linked to minimal clinical and demographic data for future risk stratification and trial read
Time frame
through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Firalis SA
Lead sponsor
CHU de Reims
Collaborator
University Hospital, Marseille
Collaborator
Centre Hospitalier Universitaire de Nice
Collaborator
University Hospital, Toulouse
Collaborator
Centre Hospitalier Universitaire de Besancon
Collaborator
University Hospital, Strasbourg, France
Collaborator
Centre Hospitalier de Colmar
Collaborator
University Hospital, Montpellier
Collaborator
Source ClinicalTrials.gov