15 February 2012

NILVAD project team holds first meeting in Dublin

The first NILVAD project meeting took place on 15-16 February in Dublin. The five year project will conduct Phase III clinical trials of the drug Nilvadipine on some 500 people with mild to moderate Alzheimer’s disease in nine European countries. The trials will determine if Nilvadipine can improve memory and functioning, but also slow the rate of progression of Alzheimer’s disease.

The meeting was chaired by Brian Lawlor (Project Coordinator and Professor of Old Age Psychiatry at Trinity College Dublin) and drew 43 delegates from the 17 partners that will work on the project (see below). Attendees discussed all of the administrative and scientific aspects of the study and established key priorities and timelines. The clinical trials will begin in late 2012 at some 20 sites in France, Germany, Greece, Hungary, Ireland, Italy, the Netherlands, Sweden and the UK. Each trial will last for 18 months, with participants receiving treatment or placebo.

Nilvadipine is a calcium channel blocker that has been used for many years to treat hypertension. Laboratory research has shown that it blocks production of the amyloid protein that is thought to be central to the Alzheimer’s disease process. Amyloid is deposited as plaques in the brains of people with Alzheimer’s disease.

In Alzheimer's mouse models, Nilvadipine was very effective at reducing development of amyloid plaques in the brain, increasing clearance of amyloid out of the brain and increasing cerebral blood flow. It also improved cognitive function in the mice.

These discoveries prompted a pilot clinical trial to determine whether Nilvadipine could be safely administered to humans with Alzheimer's disease. The trial was successful and led directly to the current NILVAD project, which will receive funding of up to EUR 6 million from the European Commission Seventh Framework Programme (FP7).

 

NILVAD partners

Country

Partner

FranceCentre Hospitalier Regional et Universitaire de Lille
Germany

GABO:mi
Universität Ulm
GreeceAristotelio Panepistimio Thessalonikis
HungaryUniversity of Szeged
Ireland





Molecular Medicine Ireland
Newsweaver
St. James's Hospital
Trinity College Dublin
University College Cork
University College Dublin
ItalyMario Negri Institute
LuxemburgAlzheimer Europe
The NetherlandsStichting Katholieke Universiteit
SwedenGoeteborgs Universitet
UKKing's College London
USAArcher Pharmaceuticals

 

24 May 2011

Clinical Trials for New Alzheimer’s Disease Treatment to be Awarded European Commission €6 million Funding

An international research  consortium led by Trinity College Dublin and involving 17 partners from Europe and the US that aims  to develop a new Alzheimer’s disease treatment has just been selected for grant funding of €6 million by the European Commission  Seventh Framework Programme (FP7). The consortium NILVAD*, comprising 18 European universities, hospitals and pharmaceutical companies, will conduct European clinical trials of NILVADIPINE in the treatment of Alzheimer’s disease (AD).

Trinity College Dublin researchers at the School of Medicine and St James’s Hospital, Dublin, are coordinating this major clinical trial that will determine whether NILVADIPINE can improve memory and also slow the rate of progression of Alzheimer’s disease. NILVADIPINE is an approved medication used for the treatment of high blood pressure and has been already shown to decrease the risk of developing dementia. There have been no new drug treatments developed for Alzheimer’s disease since 2003.

Commenting on the significance of the clinical trials and research, Professor Brian Lawlor, Conolly Norman Professor of Old Age Psychiatry at Trinity College Dublin and Consultant Psychiatrist at St James's Hospital who is leading the research said:  “Considering the devastating health and social cure impact that Alzheimer's disease has on Europeans, there is relatively little research funding made available to tackle  this major killer.  This research consortium, NILVAD represents a change in this trend in Europe and a step in the right direction.  It not only offers hope for a new treatment but also strengthens research networks and collaborations in Europe and means that research developments in Alzheimer's disease can be accelerated for the benefit of all Europeans.”

Alzheimer’s disease is an ever-increasing public health concern among the ageing 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).  It is estimated that by 2050, 1 in 85 of the population worldwide will have AD. There are few effective symptomatic treatments and as of the moment, no treatment that can delay or prevent Alzheimer’s disease.

Treating high blood pressure with medications like NILVADIPINE have been shown to decrease the risk of developing dementia and Alzheimer’s disease. In partnership with Roskamp Research Foundation in Florida, which developed the basic science evidence for the potential effectiveness of NILVADIPINE, Mercer’s Institute for Successful Ageing at St James’s Hospital, Dublin, conducted an earlier safety study also led by Professor Lawlor, on  Alzheimer’s disease patients that formed the basis for this new clinical trial. Now, in collaboration with key partners and Alzheimer’s disease experts, NILVAD will conduct these multi-centre European trials.  The trials will determine if NILVADIPINE can improve memory and functioning but also slow the rate of progression of Alzheimer’s disease. As a calcium channel blocker,   it is hoped with increased blood flow to the brain and the lowering of  amyloid levels in the brain that it will have this effect. The study will be conducted over a period of 18 months involving 500 people.  

Because NILVADIPINE is already available and licensed, this type of study can be carried out more quickly, to the potential benefit of future generations of people with Alzheimer’s disease, their caregivers and society.  

For media queries contact:    

Trinity College Dublin,  TCD Press Officer, Caoimhe Ní Lochlainn, tel: +353-1-8962310\ 087-9958014   contact

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