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Prediction of cognitive properties of new drug candidates for neurodegenerative diseases in the early clinical development

PHARMA-COG

Start Date
End Date
Total Funding
€ 30 499 556
Funding Programme

PHARMA-COG aims to develop a new integrated model to accelerate the development of drug candidates for MS, PKD and AD. The innovation relies on a 'multidimensional matrix' approach, integrating all available and renewed inputs (biomarkers/animal, human models/physiological and pharmacological challenges, Phase 0/1/1b to reduce the attrition rate, to allow an early and pertinent GO/NOGO decision before entering phase II trials for both symptomatic treatment and disease modifiers approaches. The hypothesis is that effective long term drugs will normalize markers artificially modified. The general objective is to test the efficiency of the 'matrix' on drug candidates for the enhancement/protection of cognitive functions. the final objective is to improve the detection and selection of new drugs candidates within a shorter time-frame.

Our consortium gathers 13 academics and clinicians, 8 SMEs, 1 European patient organization (Alzheimer Europe) as well as 1 regulatory body (EMEA), coming form six different EU Members States. Excellence Centres gather representatives of the different sectors: biomarkers (proteomics, transcriptomics), pharmacodynamic markers ( electrophysiology, psychophysiology, morphological and functional imaging), preclinical model specialists (cellular, transgenic mouse, monkey), clinicians, and clinical pharmacologists.

By the end of this (-year project, the following achievements are expected; definition of the most predictive combination of pharmacodynamic markers; validation of parallel models (in healthy volunteers, ApoE 4 subjects, patients and animals) to establish effective exposure ranges and support proof of mechanism studies. The predictive value of the 'matrix' will be evaluated using different pharmacological target acting drugs. Suggestions for revised/new recommendations and guidelines will help to standardize the pre-clinical and clinical phases of drugs' development in neurodegenerative diseases.

Project partners

Universita Degli Studi Di Verona

The University Of Exeter

Institut National De La Sante Et De La Recherche Medicale

Stichting Vu

Innovative Concepts In Drug Development (Icdd-Sas)

Istituto Di Ricerche Farmacologiche Mario Negri

Ucb Pharma Sa

Novartis Pharma Ag

Astrazeneca Ab

Universite De Lille Ii - Droit Et Sante

Diaxonhit Sa

F. Hoffmann-La Roche Ag

Provincia Lombardo Veneta - Ordineospedaliero Di San Giovanni Di Dio- Fatebenefratelli

Universitaet Leipzig

Eisai Limited

Sas Alzprotect

Universidad De Murcia

Irccs Fondazione Sdn Per La Ricerca E L'Alta Formazione In Diagnostica Nucleare

Consorci Institut D'Investigacions Biomediques August Pi I Sunyer

Qualissima

Universitaetsklinikum Essen

H. Lundbeck As

Boehringer Ingelheim Internationalgmbh

Innovative Health Diagnostics

Elliniki Etairia Nosoy Alzheimer Kai Syggenon Diatarachon Somateio

University Of Bristol

Universite D'Aix Marseille

Universita Degli Studi Di Foggia

Universita Degli Studi Di Genova

Institut De Recherches Servier

Universita Degli Studi Di Perugia

Centre National De La Recherche Scientifique Cnrs

Eli Lilly And Company Limited

Alzheimer Europe

Universita Cattolica Del Sacro Cuore

Janssen Pharmaceutica Nv

Merck Kgaa

Glaxosmithkline Research And Development Ltd.

 
Acknowledgement
Alzheimer Europe's database on research projects was developed as part of the 2020 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).