AFFECT WALES: A comparison between an optimised treatment protocol and standard care for the treatment of Vascular Dementia.

Not Applicable

Completed

• Conditions: Subcortical ischaemic vascular dementia; Circulatory System

• Registration Number: ISRCTN82856726
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-11
• Study Completion: 2018-08-01
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure is measured using an electronic or manual sphygmomanometer at baseline, 13, 26 and 52 weeks