A Phase III Trial of Nilvadipine to Treat Alzheimer's Disease

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.

Conditions

• Alzheimer's Disease

Interventions

DRUG

Nilvadipine

8mg of Nilvadipine taken once a day at lunch time for 78 weeks

DRUG

Placebo

8mg Placebo tablet taken once a day at lunch time for 78 weeks

Sponsors & Collaborators

• University of Dublin, Trinity College

  collaborator OTHER

• Molecular Medicine Ireland LBG

  collaborator UNKNOWN

• Alzheimer Europe

  collaborator OTHER

• Archer Pharmaceuticals, Inc.

  collaborator INDUSTRY

• E-Search Limited

  collaborator UNKNOWN

• University College Dublin

  collaborator OTHER

• King's College London

  collaborator OTHER

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• Szeged University

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• University College Cork

  collaborator OTHER

• Aristotle University Of Thessaloniki

  collaborator OTHER

• Stichting Katholieke Universiteit

  collaborator OTHER

• Prof Brian Lawlor

  lead OTHER

Principal Investigators

• Brian Lawlor, Prof · University of Dublin, Trinity College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-24

Primary Completion

2016-12-16

Completion

2016-12-16

Countries

• France
• Germany
• Greece
• Hungary
• Ireland
• Italy
• Netherlands
• Sweden
• United Kingdom

Study Locations