Home saliva tests could map Alzheimer's genetic risk across france
NCT ID NCT07679906
First seen Jul 01, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This study aims to enroll 50,000 adults aged 45 and older in France to test for a gene called APOE, which is linked to Alzheimer's risk. Participants provide a saliva sample at home and complete online questionnaires. The goal is to build a large registry of genetic and health data to better understand who is at risk and to prepare for future prevention studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could create a national registry to identify people at high genetic risk for Alzheimer's, enabling future prevention trials and personalized strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly prevent or treat Alzheimer's, and its success depends on large-scale participation and long-term follow-up.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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45 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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FIRALIS SA - Centre de Prélèvements Biologiques
RECRUITINGHuningue, 68330, France
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