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

NILVAD

Start Date
End Date
Total Funding
€ 7 916 016
Funding Programme
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 partners
E-Search Limited
University College Dublin National University Of Ireland
Dublin
Archer Pharmaceuticals Inc Corp
Molecular Medicine Ireland Lbg
Stichting Katholieke Universiteit
Aristotelio Panepistimio Thessalonikis
Istituto Di Ricerche Farmacologiche Mario Negri
Universitaet Ulm
Centre Hospitalier Regional Et Universitaire De Lille
Gabo:Mi Gesellschaft Fur Ablauforganisation:Milliarium Mbh & Co Kg
Bord Ospideil Naoimh Sheamuis
Szegedi Tudomanyegyetem
University College Cork - National University Of Ireland Cork
Goeteborgs Universitet
Alzheimer Europe
King'S College London
The Provost Fellows Foundation Scholars & The Other Members Of Board Of The College Of The Holy & Undivided Trinity Of Queen Elizabeth Near Dublin
 
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).