ADDIA Proof-of-Performance Clinical Study

Summary

The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease (AD).

ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance study with only one visit.

About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD) and 200 control subjects (healthy as compared to their age).

* 400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with moderate-to-severe AD,
* 200 patients with non-Alzheimer's neurodegenerative diseases (NAD),
* 200 controls (healthy as compared to their age).

Conditions

• Alzheimer Disease (AD)
• Frontotemporal Lobar Degeneration
• Dementia with Lewy Bodies (DLB)
• Parkinson Disease Dementia (PDD)
• Progressive Supranuclear Palsy (PSP)
• Corticobasal Degeneration (CBD)

Interventions

OTHER

volumetric MRI

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Firalis SA

  collaborator INDUSTRY

• University Hospital, Strasbourg

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois

  collaborator OTHER

• IRCCS Centro San Giovanni di Dio Fatebenefratelli

  collaborator OTHER

• Hopitaux Civils de Colmar

  collaborator OTHER

• Istanbul University

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Erasme University Hospital

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• Amoneta Diagnostics SAS

  lead INDUSTRY

Principal Investigators

• Frédéric Blanc, MD · Hôpitaux Universitaires Strasbourg

• Jean-François Démonet, MD · Centre hospitalier universitaire vaudois, Lausanne

• Hakan Gurvit, MD · Istanbul University, Istanbul

• Moira Marizzoni, PhD · IRCCS Centro San Giovanni di Dio Fatenenefratelli, Bressia

• François Sellal, MD · Hôpitaux Civils (Hopital Louis Pasteur) de Colmar

• Frisoni Giovanni, MD · University Hospital, Geneva

• Florence Pasquier, MD · Centre Hospitalier Régional, Universitaire de Lille

• Adrian Ivanoiu, MD · Cliniques Universitaires Saint-Luc, Brussels

• Bruno Dubois, MD · Assistance Publique - Hôpitaux de Paris

• Jean-Christophe Bier, MD · Hopital ERASME, Brussels

• Audrey Gabelle, MD · University Hospital, Montpellier

• Eloi Magnin, MD · Centre Hospitalier Universitaire de Besançon

• Renaud David, MD · Centre Hospitalier Universitaire de Nice

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-01

Primary Completion

2023-06-30

Completion

2023-06-30

Countries

• Belgium
• France
• Italy
• Switzerland
• Turkey (Türkiye)

Study Locations