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 (AFFECT WALES)

King's College London0 个研究点目标入组 50 人开始时间: 2016年3月11日最近更新: 2020年3月3日

适应症

试验速览

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•1. Dementia syndrome according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSMIV)
•2. Evidence of one or more clinical features in support of SIVD such as executive dysfunction, mood or gait disturbance or focal neurological signs (Erkinjuntti 2000)
•3. Multiple lacunae (>2) or diffuse lesions reaching a mean score of 23 across brain regions identified on baseline MRI scan
•4. Standardised Mini Mental State Examination (sMMSE) score between 15 and 28 (inclusive)
•5. Aged 50 and over
•6. Patient has mental capacity and is capable of giving consent
•7. Patient has resident family or professional carer or is visited at least twice a week by carer
•8. Fluency in English is essential as study requires questionnaires to be completed
•9. Likely to be able to participate in all scheduled evaluations and complete all required tests
•10. Provision of appropriate consent
•11. Presence of an informant, aged 18 years or over who is willing to participate in the study

•1. Severe, unstable or poorly controlled medical conditions apparent from physical examination or clinical history
•2. Moderate/severe heart disease or severe hepatic disease
•3. Significant renal insufficiency; estimated glomerular filtration rate (eGFR) <30ml/min
•4. Systolic Blood pressure is less than 110mmHg
•5. Cerebrovascular event within the last six months
•6. Myocardial infarction within the last three months
•7. Already taking any calcium channel blocker
•8. Treatment with immunosuppressive medications (e.g. systemic corticosteroids) within the last 90 days
•9. Other clinically significant abnormality on physical, neurological, laboratory, examination that could compromise the study or be significantly detrimental to the patient

发起方