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

Summary
EudraCT number	2012-002764-27
Trial protocol	GB IE SE HU GR NL IT DE
Global end of trial date	16 Dec 2016

Results information
Results version number	v1(current)
This version publication date	30 Aug 2018
First version publication date	30 Aug 2018
Other versions
Summary report(s)	NILVAD Clinical Study Report Synopsis

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

NILVAD2012

ISRCTN number

US NCT number

NCT02017340

WHO universal trial number (UTN)

Sponsor organisation name

St James's Hospital

Sponsor organisation address

James's Street, Dublin, Ireland, Dublin 8

Public contact

Brian Lawlor, St James's Hospital, 353 18968524, lawlorba@tcd.ie

Scientific contact

Brian Lawlor, St James's Hospital, 353 18968524, lawlorba@tcd.ie

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Jun 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

16 Dec 2016

Global end of trial reached?

Yes

Global end of trial date

16 Dec 2016

Was the trial ended prematurely?

Main objective of the trial

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.

Protection of trial subjects

Safety was assessed by physical examination, blood pressure measurements and clinical laboratory tests. Each subject partaking in the study had a blood sample taken for safety purposes, which underwent a series of clinical laboratory tests. Safety blood tests were carried out at the Screening Visit and at Week 78. All subjects had sitting and standing blood pressure (BP) measurements performed at screening, Week 0, Week 6, Week 13, Week 26, Week 39, Week 52, Week 65 and Week 78. The research clinician performed a routine physical examination and neurological examination of each subject at the screening visit. Routine evaluation of general health and wellbeing were conducted at the baseline visit and were repeated at each of the subsequent visits. These and other safety measurements as required were conducted more frequently if clinically indicated or at the discretion of the Investigator. The reason for additional observations was noted in the case report form. Any clinically significant complaints, symptoms, or other abnormalities were followed by appropriate tests and/or procedures until these values returned to normal or to clinically acceptable levels or could be attributed to causes other than the test drug(s). The investigator explained all abnormal findings in the case report form (CRF). All adverse events required reporting. Different reporting procedures were applied for differing types of adverse events. All non serious adverse events events were captured in the AE section of the CRF and sent to the Data Management coordinating centre on a regular basis for entry into the Clinical Database and inclusion in the Annual Safety Reports. All serious adverse events and suspected unexpected serious adverse events were reported to a dedicated email address at the coordinating office in Dublin in an expedited manner. Safety data was reviewed every 6 months by the independent Data Management and Safety Monitoring Board (DMSB).

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Apr 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country