A Trial of Nilvadipine in Mild to Moderate Alzheimer's disease

• Research type

  Research Study

• Full title

  A European multicenre double-blind placebo controlled phase III trial of nilvadipine in mild to moderate Alzheimer's disease.

• IRAS ID

  119468

• Contact name

  Robert Howard

• Sponsor organisation

  Trinity College Dublin

• Eudract number

  2012-002764-27

• ISRCTN Number

  n/a

• Research summary

  TITLE: A European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild to Moderate Alzheimer's disease.  DESIGN: The study employs a randomized double-blind placebo controlled parallel design.  OBJECTIVES: The objective of this study is to investigate the efficacy of Nilvadipine as a disease course modifying treatment for mild to moderate AD in a phase III double-blind placebo-controlled study and to investigate the safety profile of Nilvadipine in patients with mild to moderate AD.  OUTCOME MEASURES: The primary efficacy outcome measure in this study is the change from baseline to week 78 in cognitive function, as assessed by the Alzheimer’s -Disease Assessment Scale (ADAS -Cog 12). There are two key secondary outcome measures, the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and the Disability Assessment for Dementia (DAD).  POPULATION: A total of 500 subjects with Alzheimer's disease; 250 in the Nilvadipine group and 250 in the placebo group recruited from 31 European centres.  ELIGIBILITY: Males and females over age 50 years with mild to moderate Alzheimer's disease as defined by NINCDS-ADRDA criteria.  TREATMENT: Over encapsulated Nilvadipine 8 mg, sustained release capsule, for the treatment group, taken once a day at lunchtime or, matching over encapsulated placebo for the control group, taken once a day at lunchtime.  DURATION: The total study duration will be 82 weeks. Patients will receive study medication for 78 weeks.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/1903

• Date of REC Opinion

  4 Feb 2013

• REC opinion

  Further Information Favourable Opinion