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.

The study will compare the efficacy of 8mg nilvadipine to placebo over an 18 month trial period in subjects with mild to moderate Alzheimer’s 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 Alzheimer’s disease
The study will be conducted in line with ICH-GCP guidelines
St. James’s 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