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A European multicentre double-blind placebo-controlled phase III trial of nilvadIpine in mild to moderate Alzheimer’s disease

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.

Field of science

  • /medical and health sciences/health sciences/public and environmental health
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /medical and health sciences/basic medicine/neurology/alzheimer

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Address
College Green
2 Dublin
Ireland
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 986 380,60
Administrative Contact
David O'shea (Mr.)

Participants (16)

MOLECULAR MEDICINE IRELAND LBG
Ireland
EU contribution
€ 24 750
Address
St Stephens Green 85A
2 Dublin
Activity type
Research Organisations
Administrative Contact
Paul Barry (Mr.)
ALZHEIMER EUROPE
Luxembourg
EU contribution
€ 33 599
Address
Rue Dicks 14
1417 Luxembourg
Activity type
Other
Administrative Contact
Jean Georges (Mr.)
ARCHER PHARMACEUTICALS INC CORP
United States
EU contribution
€ 135 178
Address
Whitfield Avenue 2040
34243 Sarasota
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jerry Smith (Mr.)
E-SEARCH LIMITED
Ireland
EU contribution
€ 114 400
Address
Kinsale Road Cork Airport Business, Park Building 2200
Cork
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Margaret Flaherty (Ms.)
UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland
EU contribution
€ 122 696,40
Address
Belfield
4 Dublin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Donal Doolan (Mr.)
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 220 480,80
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs
KING'S COLLEGE LONDON
United Kingdom
EU contribution
€ 855 563
Address
Strand
WC2R 2LS London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Labbett (Mr.)
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 352 709,40
Address
Via Mario Negri 2
20156 Milano
Activity type
Research Organisations
Administrative Contact
Maria Grazia Pezzoni
CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE
France
EU contribution
€ 427 635
Address
Avenue Oscar Lambret 2
59037 Lille
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Guillaume Tueux (Mr.)
UNIVERSITAET ULM
Germany
EU contribution
€ 92 040
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Frank Gleixner (Mr.)
SZEGEDI TUDOMANYEGYETEM
Hungary
EU contribution
€ 87 540
Address
Dugonics Ter 13
6720 Szeged
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Magdolna Pákáski (Dr.)
GOETEBORGS UNIVERSITET
Sweden
EU contribution
€ 159 360
Address
Vasaparken
405 30 Goeteborg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ellen Rydberg (Dr.)
UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK
Ireland
EU contribution
€ 231 390
Address
Western Road
T12 YN60 Cork
Activity type
Higher or Secondary Education Establishments
Administrative Contact
David O Connell (Dr.)
ARISTOTELIO PANEPISTIMIO THESSALONIKIS
Greece
EU contribution
€ 511 202
Address
Kedea Building, Tritis Septemvriou, Aristotle Univ Campus
54636 Thessaloniki
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Georgia Petridou (Ms.)
STICHTING KATHOLIEKE UNIVERSITEIT
Netherlands
EU contribution
€ 539 810,60
Address
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maarten Van Langen (Mr.)
BORD OSPIDEIL NAOIMH SHEAMUIS
Ireland
EU contribution
€ 1 105 243,20
Address
James S Street
8 Dublin
Activity type
Research Organisations
Administrative Contact
Simon Moores (Mr.)