Genetic Testing for Early Alzheimer's Disease Prevention
ALZEVIT: Nationwide Digital APOE ε4 Cohort for Early Alzheimer's Disease Prevention and Trial Readiness
Recruiting
Observational Study
Alzheimer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 and older
Sex
Any
Study type
Observational
Participants needed
50,000 (estimated)
Sponsor
Firalis SA · Industry
Who this trial is looking for
This trial is looking for adults over 45 years old living in France who want to learn about their genetic risk for Alzheimer's disease. Participants will provide a saliva sample for testing and complete online assessments over time.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 45 years old.
I live in France.
I can read and understand the study information in French.
I can electronically sign the consent form.
I have access to the internet and a valid email address.
I can self-collect and return a saliva sample using a provided kit.
You may not be able to join if
I cannot sign the consent form.
I am under 45 years old.
I have known cognitive impairments or severe dementia.
I have had a substance use disorder in the past 24 months.
I cannot be contacted reliably by email or phone.
I have previously participated in this trial.
I am under guardianship or similar legal protection.
I have a physical condition that prevents me from participating.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, par…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility 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 representat…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.