Authorizations for Human Samples Transportation: Amoneta Diagnostics obtained the authorization by the French Ministry of Education and Research “Ministère de l’éducation Nationale, de l’enseignement Supérieuret de la Recherche” for human sample importation from the ADDIA Clinical centers in Italy, Switzerland, Turkey, Belgium and Canada.
Chronobiological Study Recruits: First subjects are recruited for the ADDIA chronobiological study, upon informed consents signed during 4Q 2016.
ADDIA recruited first subjects!
ADDIA PoP clinical study on 800 subjects(*) is initiated with the first subjects included on Jan 16, 2017 in Brescia and Strasbourg clinical sites; also on Feb 10 2017 in Istanbul clinical site.
*400 patients with Alzheimer’s disease, 200 with non-Alzheimer neurodegenerative diseases and 200 healthy controls.
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne/Switzerland (Prof. JF. Démonet on the right)
Chronobiological Study Initiated: The clinical chronobiological study on 12 patients with Alzheimer’s disease and 12 healthy controls is initiated, with the first informed consents signed during 4Q 2016.
ADDIA Data-Monitoring Assured: Amoneta Diagnostics S.A.S., coordinator of the ADDIA Project, signed a contract with DrPospichal-Mediante GmbH for the data monitoring of the ADDIA Proof-Of-Performance (PoP) clinical study. DrPospichal-Mediante GmbH is an independent contract research organizations (CROs) based in Germany, with experience in providing clinical research services to the biopharmaceutical industry and life science organizations.
Amoneta signs for ADDIA e-CRF Service: Amoneta Diagnostics S.A.S., coordinator of the ADDIA Project, signed a contract with Absilon to perform the Electronic Clinical Research Form (e-CRF) of the ADDIA Proof-Of-Performance (PoP) clinical study. Absilon is an independent CRO based in France, with experience in providing clinical research services to the biopharmaceutical industry.
ADDIA obtains Ethic Committee Approvals: Amoneta Diagnostics SAS successfully submitted the ADDIA PoP clinical study package to and obtained approval from the ethic committees of France on 4-Jul-2016, Italy on 19-Oct-2016, Turkey on 28-Jun-2016, Switzerland on 5-Sep-2016 as well as from the French “Agence Nationale de Sécurité du Médicament et des Produits de Santé” on 1-July-2016.
ADDIA Chronobiological Study obtains Approvals: Amoneta Diagnostics S.A.S. obtained the approval from the French ethic committees “Comité de Protection des Personnes” (CPP) also on June 14, 2016 from the ”Agence Nationale de Sécurité du Médicament et des Produits de Santé” (ANSM) for its chronobiological study that will include patients with Alzheimer’s disease and healthy controls.
ADDIA Project launched with a Consortium Kick-off Meeting
In coordination of Amoneta Diagnostics S.A.S. and with participation of several clinical centers, ADDIA project is launched via an excellent kick-off meeting, in the administrative site of Amoneta in Huningue, at the triple border of France, Switzerland (Basel Region) and Germany (Freiburg). All parties have represented their institutes, specialities and capabilities by focused and uniformed presentations.
Firalis S.A., the parent company of Amoneta Diagnostics S.A.S. and a partner of ADDIA project (as third linked party), as well as other stakeholders such as consultants and outsourcing partners, were also present at the meeting.
Next step is to have further discussions with each of the stakeholders and clinical centers in particular, in order to prepare the clinical trial in a best possbile configuration.