WP05 - Clinical Platform - Nilvadipine Clinical Trial

Objectives

  • To conduct an investigator initiated European multi-centre clinical trial according to ICH-GCP guidelines and in accordance with the regulatory and ethical frameworks of each participating country.
  • To enroll 500 patients with mild to moderate AD.
  • To assess the symptomatic and disease modifying benefit of nilvadipine using cognitive and global efficacy endpoints.
  • To assess the safety of nilvadipine in mild to moderate AD.
  • To collect, store, transport and analyse research samples for biomarker levels.
  • To examine the modifying effects of potential multimodal therapeutic interventions such as frailty, exercise level, nutritional status and social connection on treatment outcome.
  • To ensure that the study is monitored and audited according to pre-defined parameters.
  • To complete the clinical trial on-time and within budget.

Workpackage Description

  • The study will compare the efficacy of 8mg nilvadipine to placebo over an 18 month trial period in subjects with mild to moderate Alzheimerís disease (sMMSE 12-26 at screening)
  • The primary efficacy measure will be change from baseline on ADAS-cog 11
  • Investigator sites have been selected in 9 European countries (Ireland, UK, France, Hungary, Italy, Sweden, Greece, Germany and the Netherlands for their excellence and experience in conducting clinical trials in Alzheimerís disease
  • The study will be conducted in line with ICH-GCP guidelines
  • St. Jamesís Hospital Dublin will act as sponsor of the clinical trial
  • Ethics approval will be obtained in each country and regulatory approval for the use of nilvadipine will be obtained using the Voluntary Harmonisation Procedure
  • Indemnity for the study will be provided by a commercial insurer
  • Clinical monitoring will be provided by academic clinical trials units at each site where available and commercial CROs in countries where there are no academic trials units
  • Overall responsibility and oversight for site monitoring will be by the coordinator and scientific project manager in TCD
  • Data management and randomisation of subjects will be carried out through the KCL Clinical Trials Unit in London
  • There will be an independent Data Monitoring and Ethics Committee and an external Scientific Advisory Board as part of the trial governance

WP Leader

Trinity College Dublin (Prof. Brian Lawlor)