AFFECT Trial

  • Research type

    Research Study

  • Full title

    A randomised controlled trial of calcium channel blockade with amlodipine for the treatment of subcortical ischaemic vascular dementia

  • IRAS ID

    151131

  • Contact name

    Peter Passmore

  • Contact email

    p.passmore@qub.ac.uk

  • Sponsor organisation

    Belfast Health and Social Care Trust

  • Eudract number

    2014-000926-39

  • ISRCTN Number

    ISRCTN31208535

  • Research summary

    Dementia affects approximately 35.6 million people worldwide with the number expected to rise significantly in the next decade. Vascular dementia (VaD) is the second most common cause of dementia accounting for 20% of all dementia cases. The condition is caused by problems with the blood supply to the brain, for example following a stroke or due to damage to the tiny blood vessel network in the brain. The resulting damage causes cells to be lost, leading to the development of dementia. The most common form of vascular dementia is subcortical ischemic vascular dementia (SIVD), affecting up to 67% of people with vascular dementia.
    To date there has been minimal investment in treatment for people with vascular dementia despite the large numbers of people affected by the condition. As a result there are no drugs licensed for the treatment of vascular dementia and no on-going clinical trials are registered. The aim of this study is to investigate whether treatment with the calcium channel blocker medication amlodipine, can improve outcomes for people with SIVD.
    This study is funded by the Alzheimer's Society and British Heart Foundation. It is a randomised placebo-controlled trial involving 588 people aged 50 years or over with SIVD taking place in an outpatient setting across Northern Ireland, England and Scotland.
    Patients will be enrolled in the trial for 2 years; 1 year on study treatment and a follow up telephone call at the end of year 2, Patients will undergo an MRI brain scan at the start of the study to confirm diagnosis and after 1 year to monitor progress. During the trial, patients and an informant (friend, relative or professional carer) will attend the clinic at various intervals and both will be asked to complete questionnaires with the help of an assessor.

  • REC name

    HSC REC A

  • REC reference

    14/NI/0069

  • Date of REC Opinion

    23 Jun 2014

  • REC opinion

    Further Information Favourable Opinion