What is this study trying to find out about Alzheimer's disease?

This study aims to create a large-scale genetic registry for Alzheimer's disease risk based on APOE genotyping. Researchers want to identify individuals at high genetic risk and understand disease progression to support early prevention and treatment strategies. It is sponsored by Firalis SA and involves collaboration with French memory research centers.

Who may be eligible for this Alzheimer's clinical trial?

Adults aged 45 years or older living in France who can read and understand French and provide electronic consent may be eligible. Participants must have internet access and be able to collect a saliva sample at home. Please review eligibility criteria for more details.

Is there any cost to participate in this Alzheimer's clinical trial?

Study-related care, including genetic testing and all trial activities, is provided at no cost. Personal travel or mailing expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 45Years +

All Genders

Healthy Volunteers

ID07679906

ALZEVIT A Nationwide Digital Study in France for APOE Genetic Testing and Early Alzheimers Disease Prevention

Led by Firalis SA · Updated on 2026-07-01

50000

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting ALZEVIT, a large, nationwide, decentralized observational study in France focused on Alzheimers disease AD prevention. This study aims to create a large-scale Apolipoprotein E APOE genotyping registry and enable precision prevention strategies, especially targeting people at high genetic risk like APOE 4 carriers and homozygotes. It addresses the need for early detection of individuals at risk to support emerging disease-modifying therapies most effective in early or preclinical stages. Participants aged 45 and older enroll online, provide electronic consent, and self-collect saliva samples at home using a provided kit for centralized APOE genotyping. Phase A first 18 months will enroll 50,000 participants to determine APOE genotype distribution and evaluate large-scale digital genetic screening feasibility with ongoing online cognitive and risk factor assessments. Phase B months 12-24 involves detailed testing of about 2,350 participants representing all APOE genotypes, including clinical evaluations, MRI scans, cognitive tests, and advanced biomarker profiling conducted at memory centers or via telemedicine. Participants provide self-reported health, lifestyle, and cognitive information through questionnaires and complete validated cognitive assessments over time. Researchers collect biosamples for multi-omics analyses and classify participants along the cognitive spectrum from normal to mild or moderate AD. The study monitors cognitive changes, biomarker evolution, and risk or resilience factors to better understand APOE-related disease pathways. Data are securely stored under GDPR, supporting future prevention trials and precision medicine approaches for Alzheimers disease.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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 (ORAcollect4 Dx device).

You will not qualify if you...

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.

Research Team

Hüseyin FIRAT, MD, PhD, HDR

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ALZEVIT A Nationwide Digital Study in France for APOE Genetic Testing and Early Alzheimers Disease Prevention

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria