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NILVAD

Even modest therapeutic advances that delay Alzheimer’s 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 Alzheimer’s, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments that have disease modifying effects.

The NILVAD consortium consists of 17 participating institutions based in ten different European Union member states as well as Archer Pharmaceuticals. It will mobilize the synergies of the major relevant European research groups to conduct a clinical trial on the efficacy of nilvadipine in Alzheimer's Disease. The NILVAD consortium is formed by renowned researchers from all over Europe and USA, each one with a strong scientific and/or clinical background in the fields of Alzheimer's disease and dementia. Excellent research standards - including the latest scientific and technological advances - are the basis for the NILVAD Project, A European multicentre double-blind placebo-controlled phase III trial of nilvadipine in mild to moderate Alzheimer’s disease) coordinated by Trinity College Dublin, Ireland.

The European Commission funds NILVAD for five years and 6 million Euros, through the European Union Seventh Framework Programme (FP7) www.nilvad.eu

This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate Alzheimer's Disease over a treatment period of 18 months. Male and female patients with mild to moderate Alzheimer's Disease 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 Alzheimer's Disease patients and would have a major impact on the health and social care costs incurred by this neurodegenerative disorder.

The NILVAD Study protocol has been published in the journal BMJ Open:
NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease.
Lawlor B, Kennelly S, O'Dwyer S, Cregg F, Walsh C, Coen R, Kenny RA, Howard R, Murphy C, Adams J, Daly L, Segurado R, Gaynor S, Crawford F, Mullan M, Lucca U, Banzi R, Pasquier F, Breuilh L, Riepe M, Kalman J, Wallin A, Borjesson A, Molloy W, Tsolaki M, Olde Rikkert M.
BMJ Open. 2014 Oct 9;4(10):e006364. doi: 10.1136/bmjopen-2014-006364. Erratum in: BMJ Open. 2015;5(9):e006364. (pdf download)
 

Read more about Archer's participation in the NILVAD study in the April, 2013 NILVAD Newsletter.