AFFECT

Trial Acronym	AFFECT
Clinical Area	Dementia
Description	A randomised controlled trial of calcium channel blockade with amlodipine for the treatment of subcortical ischaemic vascular dementia.
Status	Closed

RECRUITMENT

Date Opened to Recruitment	December 2014
Target Recruitment	588
Recruitment to date	11(Completed)

TRIAL DESIGN

Trial Design	The AFFECT trial is a multi-centre, randomised, double-blind, placebo-controlled, parallel phase IIb trial of amlodipine in patients with subcortical ischaemic vascular dementia (SIVD).
Study Aim	The aim of this study is to test the hypothesis that treatment with amlodipine for 52 weeks can improve outcomes for patients with SIVD. The objectives of this study are:
	Primary:To determine whether amlodipine will confer significant benefit with respect to change in cognitive outcome in people with SIVD in comparison to placebo over 52 weeks.
	Secondary: (i) To determine whether amlodipine will confer additional benefits on the following secondary outcomes; global impression, activities of daily living, neuropsychiatric symptoms and carer burden, in comparison to placebo (ii) To determine if amlodipine will be a cost effective treatment for SIVD compared to placebo.

CHIEF INVESTIGATOR (CI)

Chief Investigator

Professor Peter Passmore

SPONSOR(s) & FUNDER(s)

Sponsor	Belfast Health and Social Care Trust
Funder	Alzheimer’s Society/British Heart Foundation