A Randomised Controlled Trial of Calcium Channel Blockade (CCB) with Amlodipine for Treatment of Subcortical Ischaemic Vascular Dementia (AFFECT) | C4C

The study is a 12-month, multi-centre randomized double- blind placebo- controlled clinical trial to find out whether the anti-high blood pressure medication amlodipine is an effective treatment in people with the commonest sub-type of vascular dementia ( Subcortical Ischaemic Vascular Dementia -SIVD). Participants will have a 50:50 chance of receiving amlodipine or identical matching placebo (dummy treatment). Participants will be maintained at the highest well-tolerated dose level (either 5 or 10 mg). Patients will be recruited and monitored at multiple sites across Northern Ireland, Scotland, England and London. 588 people (294 per treatment group) with SIVD will be included, as defined by standardized diagnostic criteria (DSM-IV) and evidence of extensive changes in the white matter part of the brain on an MRI or CT brain scan. Recruitment will be completed over 24 months, with 12 months of follow-up for patients who receive amlodipine (CCB) or placebo for 52 weeks (12 months) with a telephone follow up at 104 weeks (24 months). All the assessments will be carried at the CRF at the King’s College Hospital by the research team from the Wolfson Centre for Age-Related Diseases (King’s College London) and the BRU-D field team. The team will include qualified study doctors, consultant psychiatrists, research nurses and raters/ psychologists. The Screening visit includes medical history, previous and current medications, inclusion/exclusion criteria evaluated, vital signs, height and weight, physical and neurological examinations, ECG, MMSE, blood tests and an MRI scan to confirm the diagnosis of SIVD. The baseline and outcome visits will include a number of cognitive assessments to look at change in attention, planning, memory and other higher brain functions; an overall assessment of outcome, every day function, psychiatric symptoms and quality of life. Follow up visits will take place at week 2 (telephone follow up), week 4 (telephone follow up), week 6, week 13, week 26, week 39, week 52. The TICS telephone memory test will be repeated at week 26, week 52 and week 104.