NILVAD: An investigator initiated multi-centre placebo-controlled phase III trial of Nilvadipine, a calcium channel blocker, in mild-to-moderate Alzheimer's disease

There is a clear unmet medical and public health need for the development of new treatments for Alzheimer's Disease (AD) that have both symptomatic and disease modifying effects. NILVAD comprises a new consortium of research partners, clinical sites and advocacy groups in Europe created around FP7-Health 2011 that is proposing to test the efficacy and safety of nilvadipine versus placebo in mild to moderate AD. There is a very strong scientific rationale for the study: Nilvadipine, a calcium channel blocker that is already licensed for the treatment of hypertension in Europe, enhances Aß clearance from brain and restores cortical perfusion in transgenic mouse models of AD. We have previously demonstrated that nilvadipine is safe and well tolerated in AD patients. Furthermore, clinical studies of nilvadipine have shown stabilization of cognitive decline and reduced incidence of AD in hypertensive subjects with mild cognitive impairment, indicating that this medication may have both symptomatic and disease modifying benefit. We are planning to enroll 500 male and female patients with mild to moderate AD aged between the ages of 50 and 85 with a range of medical morbidities and frailty in the study. We will also examine the modifying effects of leisure activities and social engagement on treatment outcome to inform future multi-modal therapeutic interventions. If effective, nilvadipine would represent a significant development in the treatment approaches that currently exist for AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. In addition, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe. This investigator initiated clinical trial can only be delivered successfully by cooperation between expert clinicians, and large and small industry partners in cooperation with AD patients, their caregivers and the support of advocacy groups working through a network of clinical sites across Europe. The project is expected to start in early 2012, pending the successful completion of negotiations with the EC.