Download SECTION 2 TECHNICAL REQUIREMENTS

SECTION 2 TECHNICAL REQUIREMENTS
2.1 Background
NILVAD is a new consortium of research partners, clinical sites and advocacy groups in
Europe created around the FP7-Health 2011 initiative and co-ordinated by Professor Brian
Lawlor of Trinity College Dublin Ireland. NILVAD has just been listed for grant funding of € 6
million the European Commission FP 7 Research Framework Programme to conduct an
investigator initiated multi-centre European treatment trial of NILVADIPINE, a medication
already licensed for blood pressure control, in Alzheimer’s disease.
Alzheimer’s disease is now the most expensive illness worldwide in terms of health and
social care costs and the numbers of people who will develop this disease are projected to
double by 2050, making this illness a major research priority for European Community.
There are few effective symptomatic treatments and as of the moment, no treatment that
can delay or prevent Alzheimer’s disease. NILVADIPINE is a medication already approved
and used in many European countries for the treatment of high blood pressure. Treating
high blood pressure with medications like NILVADIPINE have been show to decrease the risk
of developing dementia and Alzheimer’s disease. In partnership with Roskamp Research
Foundation in Florida, who 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 in Alzheimer’s disease patients that
formed the basis for the clinical trial. Now, in collaboration with key partners and Alzheimer’s
disease experts at University of London, Cork, Nimijen, Goteberg, Ulm, Milan, Budapest and
Thessaloniki, and following successful completion of negotiations with the EC, NILVAD will
conduct this multi-centre European trial to determine if NILVADIPINE can improve memory
and functioning but also slow the rate of progression on Alzheimer’s disease. NILVAD plans
to start the planning phase of the trial in January 2012, with recruitment beginning in the
latter part of 2012, pending conclusion of negotiations with the EC in September 2011.
NILVAD is an exciting development in the field. There have been no new drug treatments
developed for Alzheimer’s disease since 2003 and there is a clear unmet need for patients
and society. NILVAD will create a new research network throughout Europe and show
whether a novel approach with increases blood flow to the brain and lowers amyloid levels
in the brain can make an impact in Alzheimer’s disease. 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.
A European Multicentre Double Blind Placebo Controlled trial of Nilvadipine in Mild to
moderate Alzheimer’s disease is to be undertaken
2.2 Trial Over view
The trial is a Non-commercial, double-blind, randomised, placebo-controlled trial.
The trial is to utilise Nilvadipine 8mg and placebo-to-match.
Patients will either receive Nilvadipine 8mg ONCE daily or placebo to match for 18 months.
500 patients will be involved (250 active/250 placebo) + 10% excess for withdrawals.
The trial will take place 9 countries with 21 sites (EU multi-centre) as listed below.
Country
Ireland
United Kingdom
Hungary
Number of Sites
2
1
1
Sweden
Germany
Greece
Italy
France
Netherlands
1
1
1
4
6
4
The patient recruitment duration will be 12 months. It is proposed that this will occur from
September 2012 until August 2013. Patients are enrolled in the study for a total of 18
months.
2.3 Trial Objectives and Overview
The objectives of this trial/study are to;
▪To augment the initial studies of Nilvadipine as a treatment for AD by investigating its
efficacy in a phase III double-blind placebo-controlled study
▪ To demonstrate the feasibility of a multi-site European clinical trial of a potential AD
treatment with a demonstrated safety profile.
▪ To promote a European clinical trial network of AD clinicians and researchers
▪ To expedite availability of effective treatment to AD patients by advancing a promising,
safe, anti-Alzheimer drug through Phase III clinical trials.
▪ To financially support the large scale investigation of Nilvadipine in AD patients which the
existing preclinical and clinical data strongly mandate.
▪ Ultimately, to improve treatment options and quality of life for people with Alzheimer’s
disease in Europe
The study will employ a randomized double-blind placebo controlled parallel design and will
be for an 18 months duration.
The study will take across Europe. There will be sites in Ireland, UK, France, Greece,
Hungary Netherlands, Sweden, Germany, Austria and Italy
500 subjects will be included within the study, 250 in the Nilvadipine group and 250 in the
placebo group
2.4 Tender Requirements
The CA requires Tenderers to submit proposals for the project management and monitoring
of this alzheimers Phase III drug clinical trial in Hungary and/or Greece. It is anticipated
that there will be one site in Hungary, which anticipate recruiting 38 patients and one in
Greece who anticipate recruiting…
The following categories along with a break down of costs should be outlined in the quotes.
Project Management
Start up including regulatory and
ethics submissions
Study Duration
Monitoring
Site Initiation
Site Monitoring
Site Close Out
Site management
Investigator File Management
Start-Up Training Meeting
Project Team Meetings
Administration Support
Sub Total Monitoring/Site
Management
Pass Through Costs
Travel
Start-up meeting
Site Pre-Study Feasibility
Site Initation
Site Monitoring
Site Close Out
EC Fees
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