A Phase III Trial of Nilvadipine to Treat Alzheimer's Disease
Status:
Completed
Trial end date:
2016-12-16
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Prof Brian Lawlor
Collaborators:
Alzheimer Europe Archer Pharmaceuticals, Inc. Aristotle University Of Thessaloniki E-Search Limited GABO:mi Goeteborgs Universitet Göteborg University Istituto Di Ricerche Farmacologiche Mario Negri King's College London Molecular Medicine Ireland LBG Stichting Katholieke Universiteit Szeged University University College Cork University College Dublin University Hospital, Lille University of Dublin, Trinity College University of Ulm