NILVAD
A European multicentre double-blind placebo-controlled phase III trial of nilvadIpine in mild to moderate Alzheimer’s disease
| Coordinatore | THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Organization address
address: College Green - contact info |
| Nazionalità Coordinatore | Ireland [IE] |
| Sito del progetto | http://www.nilvad.eu/ |
| Totale costo | 7˙880˙918 € |
| EC contributo | 5˙999˙978 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2011-two-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2012 |
| Periodo (anno-mese-giorno) | 2012-01-01 - 2016-12-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Organization address
address: College Green - contact info |
IE (DUBLIN) | coordinator | 945˙260.00 |
| 2 |
BORD OSPIDEIL NAOIMH SHEAMUIS
Organization address
address: JAMES S STREET contact info |
IE (DUBLIN) | participant | 996˙884.00 |
| 3 |
KING'S COLLEGE LONDON
Organization address
address: Strand contact info |
UK (LONDON) | participant | 827˙013.00 |
| 4 |
STICHTING KATHOLIEKE UNIVERSITEIT
Organization address
address: GEERT GROOTEPLEIN NOORD 9 contact info |
NL (NIJMEGEN) | participant | 551˙030.00 |
| 5 |
ARISTOTELIO PANEPISTIMIO THESSALONIKIS
Organization address
address: Administration Building, University Campus contact info |
EL (THESSALONIKI) | participant | 510˙050.00 |
| 6 |
CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE
Organization address
address: AVENUE OSCAR LAMBRET 2 contact info |
FR (LILLE) | participant | 438˙855.00 |
| 7 |
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG GAB O
Organization address
address: Oskar-von-Miller-Ring 29 contact info |
DE (MUENCHEN) | participant | 390˙000.00 |
| 8 |
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Organization address
address: Via Giuseppe La Masa 19 contact info |
IT (MILANO) | participant | 324˙659.00 |
| 9 |
UNIVERSITY COLLEGE CORK, NATIONAL UNIVERSITY OF IRELAND, CORK
Organization address
address: Western Road contact info |
IE (CORK) | participant | 237˙000.00 |
| 10 |
SZEGEDI TUDOMANYEGYETEM
Organization address
address: DUGONICS TER 13 contact info |
HU (SZEGED) | participant | 177˙300.00 |
| 11 |
ARCHER PHARMACEUTICALS INC CORP
Organization address
address: WHITFIELD AVENUE 2040 contact info |
US (SARASOTA) | participant | 135˙178.00 |
| 12 |
GOETEBORGS UNIVERSITET
Organization address
address: VASAPARKEN contact info |
SE (GOETEBORG) | participant | 125˙700.00 |
| 13 |
UNIVERSITAET ULM
Organization address
address: HELMHOLTZSTRASSE 16 contact info |
DE (ULM) | participant | 125˙700.00 |
| 14 |
E-SEARCH LIMITED
Organization address
address: "KINSALE ROAD CORK AIRPORT BUSINESS, PARK BUILDING 2200" contact info |
IE (CORK) | participant | 114˙400.00 |
| 15 |
UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Organization address
address: BELFIELD contact info |
IE (DUBLIN) | participant | 42˙600.00 |
| 16 |
ALZHEIMER EUROPE
Organization address
address: route de Thionville 145 contact info |
LU (Luxembourg) | participant | 33˙599.00 |
| 17 |
MOLECULAR MEDICINE IRELAND LBG
Organization address
address: ST STEPHENS GREEN 85A contact info |
IE (DUBLIN) | participant | 24˙750.00 |
Mappa
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Obiettivo del progetto (Objective)
'Alzheimer’s disease (AD) is an ever-increasing public health concern among the aging population and is the most common form of dementia affecting more than 15 million individuals worldwide and around 5 million Europeans. The direct and indirect costs of AD and other dementias amount to more than €440,000 million each year (www.alz.org, 2010).
Even modest therapeutic advances that delay disease onset and progression could significantly reduce the global burden of the disease and the level of care required by patients. While there are symptomatic-based drug therapies available for AD, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments for AD that have disease modifying effects.
This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical studies with this medication have shown stabilization of cognitive decline and reduced incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities and frailty will be included in the study. If this trial is successful, nilvadipine would represent an advance in the treatment of AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe.'