AFFECT Wales

• Research type

  Research Study

• Full title

  A randomised controlled trial of an optimized protocol for blood pressure management (prioritizing calcium channel blockade with amlodipine) for the treatment of subcortical ischaemic vascular dementia.

• IRAS ID

  203341

• Contact name

  Clive Ballard

• Contact email

  C.Ballard@exeter.ac.uk

• Sponsor organisation

  King's College London

• ISRCTN Number

  ISRCTN82856726

• Duration of Study in the UK

  2 years, 3 months, 0 days

• 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 two thirds of people with vascular dementia.
  To date there has been minimal investment in treatments 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 ongoing clinical trials are registered. The aim of this study is to investigate the feasibility of a treatment approach to implement an optimized treatment protocol to reduce blood pressure and prioritize treatment with the calcium channel blocker medication amlodipine, to inform the development of a further clinical trial to see whether this treatment approach can improve long term outcomes for people with SIVD. This study is funded by the Waterloo foundation and will involve 50 people aged 50 years or over with SIVD in Wales. Participants will be enrolled in the trial for 1 year ; Participants will undergo an MRI brain scan at the start of the study to confirm diagnosis and after 1 year to monitor changes in the severity of their SIVD. 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

  South Central - Oxford B Research Ethics Committee

• REC reference

  16/SC/0237

• Date of REC Opinion

  16 May 2016

• REC opinion

  Unfavourable Opinion