## Protocol Section
### Identification Module
**NCT ID:** NCT06432192

**Acronym:** ApoDiag

**Brief Title:** A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis

**Official Title:** ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis

#### Organization Study ID Info
**ID:** 2023-A02120-45
#### Organization
**Class:** INDUSTRY
**Full Name:** Firalis SA
### Status Module
#### Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Firalis SA

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability.

The present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools.

### Conditions Module

**Conditions:**

- Genetic Health Risks

**Keywords:**

- Polygenic risk, APOE, Apolipoprotein, Neurodegenerative disorders, dementia, Alzheimer disease, genetic risks

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The cohort will be genotyped to determine the phenotype of the APOE allele

**Intervention Names:**

- Diagnostic Test: APO-Easy

**Label:** APOE E

### Interventions

#### Intervention 1

**Arm Group Labels:**

- APOE E

**Description:** Testing for the APOE genotype using the APO-Easy Genotyping test

**Name:** APO-Easy

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Establish the feasibility of detecting several gene mutations associated with the risk of Alzheimer's disease/ Cardiovascular disorder and validation of analytical parameters

**Measure:** APOE Genotype

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** Establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C.

**Measure:** Specimen stability

**Time Frame:** Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Donors who sign the informed consent forms for sample collection and for genotyping.
* Adults, both genders, aged 18-85 years.
* Not under any administrative or legal supervision

Exclusion Criteria:

* Anyone who did not sign the Informed Consent form.
* Subjects aged below 18 years and older than 85 years are excluded.
* Pregnant, parturient and nursing women are excluded

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Healthy donors

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinical@firalis.com

**Name:** Rodwell Mkhwananzi, MD

**Phone:** 03 89 91 13 20

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Strasbourg

**Contacts:**

***Contact 1:***

- **Email:** Catherine.humbrecht@efs.sante.fr

- **Name:** Catherine HUMBRECHT, MD

- **Phone:** 03 88 21 25 25

- **Role:** CONTACT

**Country:** France

**Facility:** EFS GEST

**Status:** RECRUITING

**Zip:** 67000

#### Overall Officials

**Official 1:**

**Affiliation:** Firalis SA

**Name:** Huseyin Firat, MD PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M3885

- Name: Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
