A european multicentre double-blind placebo-controlled phase iii trial of nilvadipine in mild to moderate alzheimer’s disease

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Project Title: A european multicentre double-blind placebo-controlled phase iii trial of nilvadipine in mild to moderate alzheimer’s disease
Project Number: CORDIS-102240
Project web address: Follow on CORDIS
Organization: The Provost, Fellows, Foundation Scholars & The Other Members Of Board Of The College Of The Holy & Undivided Trinity Of Queen Elizabeth Near Dublin, Ireland, Dublin
Collaborators: King'S College London, GB
University Of Ulm, DE
Stichting Katholieke Universiteit, NL
Archer Pharmaceuticals, Inc., US
University College Cork, National University Of Ireland, Cork, IE
Istituto Di Ricerche Farmacologiche Mario Negri, IT
Centre Hospitalier Régional Et Universitaire De Lille, FR
University College Dublin, National University Of Ireland, Dublin, IE
Alzheimer Europe, LU
Aristotelio Panepistimio Thessalonikis, GR
Szegedi Tudomanyegyetem, HU
Gabo:Mi Gesellschaft Für Ablauforganisation :Milliarium Mbh & Co. Kg, DE
Molecular Medicine Ireland Lbg, IE
Bord Ospideil Naoimh Sheamuis, IE
E-Search Limited, IE
Principal Investigators (PI): Jean Georges, LU
Paul Labbett, GB
Donal Doolan, IE
Birgit Fuchs, DE
Georgia Petridou, GR
Maria Grazia Pezzoni, IT
Frank Gleixner, DE
Paul Barry, IE
Ellen Rydberg, SE
Maarten Van Langen, NL
David O Connell, IE
Guillaume Tueux, FR
Magdolna Pákáski, HU
Jerry Smith, US
Brian Fitzgerald, IE
Margaret Flaherty, IE
David O'Shea, IE
 
Project Description:
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.
 
Project Terms:
life sciences
Project Title: A european multicentre double-blind placebo-controlled phase iii trial of nilvadipine in mild to moderate alzheimer’s disease
Project Number: CORDIS-102240
Project web address: Follow on CORDIS
Organization: The Provost, Fellows, Foundation Scholars & The Other Members Of Board Of The College Of The Holy & Undivided Trinity Of Queen Elizabeth Near Dublin, Ireland, Dublin
Collaborators: King'S College London, GB
University Of Ulm, DE
Stichting Katholieke Universiteit, NL
Archer Pharmaceuticals, Inc., US
University College Cork, National University Of Ireland, Cork, IE
Istituto Di Ricerche Farmacologiche Mario Negri, IT
Centre Hospitalier Régional Et Universitaire De Lille, FR
University College Dublin, National University Of Ireland, Dublin, IE
Alzheimer Europe, LU
Aristotelio Panepistimio Thessalonikis, GR
Szegedi Tudomanyegyetem, HU
Gabo:Mi Gesellschaft Für Ablauforganisation :Milliarium Mbh & Co. Kg, DE
Molecular Medicine Ireland Lbg, IE
Bord Ospideil Naoimh Sheamuis, IE
E-Search Limited, IE
Principal Investigators (PI): Jean Georges, LU
Paul Labbett, GB
Donal Doolan, IE
Birgit Fuchs, DE
Georgia Petridou, GR
Maria Grazia Pezzoni, IT
Frank Gleixner, DE
Paul Barry, IE
Ellen Rydberg, SE
Maarten Van Langen, NL
David O Connell, IE
Guillaume Tueux, FR
Magdolna Pákáski, HU
Jerry Smith, US
Brian Fitzgerald, IE
Margaret Flaherty, IE
David O'Shea, IE
 
Project Categories:
Natural Sciences > Aging Diseases and Pathology > Neurodegenerative diseases > Alzheimer's disease
 
Other Information:
Fiscal Year: 2012
Project Start Date: 1 January 2011
Project End Date: 31 December 2016
Project program: FP7-HEALTH
 
Project Funding Information:
Funding Mechanism: CP-FP - Small or medium-scale focused research project
Year Funding Organization Total Funding, $
2012 European Research Council $8,686,528
Project Title: A european multicentre double-blind placebo-controlled phase iii trial of nilvadipine in mild to moderate alzheimer’s disease
Project Number: CORDIS-102240
Project web address: Follow on CORDIS
Organization: The Provost, Fellows, Foundation Scholars & The Other Members Of Board Of The College Of The Holy & Undivided Trinity Of Queen Elizabeth Near Dublin, Ireland, Dublin
Collaborators: King'S College London, GB
University Of Ulm, DE
Stichting Katholieke Universiteit, NL
Archer Pharmaceuticals, Inc., US
University College Cork, National University Of Ireland, Cork, IE
Istituto Di Ricerche Farmacologiche Mario Negri, IT
Centre Hospitalier Régional Et Universitaire De Lille, FR
University College Dublin, National University Of Ireland, Dublin, IE
Alzheimer Europe, LU
Aristotelio Panepistimio Thessalonikis, GR
Szegedi Tudomanyegyetem, HU
Gabo:Mi Gesellschaft Für Ablauforganisation :Milliarium Mbh & Co. Kg, DE
Molecular Medicine Ireland Lbg, IE
Bord Ospideil Naoimh Sheamuis, IE
E-Search Limited, IE
Principal Investigators (PI): Jean Georges, LU
Paul Labbett, GB
Donal Doolan, IE
Birgit Fuchs, DE
Georgia Petridou, GR
Maria Grazia Pezzoni, IT
Frank Gleixner, DE
Paul Barry, IE
Ellen Rydberg, SE
Maarten Van Langen, NL
David O Connell, IE
Guillaume Tueux, FR
Magdolna Pákáski, HU
Jerry Smith, US
Brian Fitzgerald, IE
Margaret Flaherty, IE
David O'Shea, IE
 
Project Title Organization FY Funding
A European Multicentre Double-Blind Placebo-Controlled Phase Iii Trial Of Nilvadipine In Mild To Moderate Alzheimer’S DiseaseThe Provost, Fellows, Foundation Scholars & The Other Members Of Board Of The College Of The Holy & Undivided Trinity Of Queen Elizabeth Near Dublin2012$8,686,528