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

Obiettivo

PHARMA-COG aims to develop a new integrated model to accelerate the development of drug cindidates 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 pharmcological 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 teim-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. Suugestions for revised/new recomendations and guidellines will help to standardize the pre-clinical and clinical phases of drugs' development in neurodegenerative diseases.

Campo scientifico

Programma(i)

Argomento(i)

Invito a presentare proposte

IMI-JU-01-2008
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Meccanismo di finanziamento

JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)

Coordinatore

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
Contributo UE
Nessun dato
Indirizzo
Great West Road 980
TW89GS Brentford
Regno Unito

Mostra sulla mappa
Regione
London Outer London — West and North West Hounslow and Richmond upon Thames
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contatto amministrativo
Graham Ian Somers (Dr.)
Ricercatore principale
Jill C Richardson (Dr.)
Collegamenti
Costo totale
Nessun dato

Partecipanti (37)

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Ultimo aggiornamento: 5 Aprile 2023

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Permalink: https://cordis.europa.eu/project/id/115009/it

European Union, 2024