Subcortical ischaemic vascular dementia Circulatory System Subcortical ischaemic vascular dementia
Conditions
Interventions
After informed consent and once all eligibility criteria have been confirmed, patients will be randomised to the study intervention or usual treatment.
Optimised treatment arm: Partic
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic and diastolic blood pressure is measured using an electronic or manual sphygmomanometer at baseline, 13, 26 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognitive function is measured using the Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog) at baseline, 13, 26 and 52 weeks 2. Cognitive function measured with the Standardized Mini-Mental State Examination (SMMSE) at baseline, 13, 26 and 52 weeks 3. Executive function is measured using the Trail Making test B at baseline, 13, 26 and 52 weeks 4. Clinical outcome is measured using the Clinical Global Impressions (CGI) Scale, as rated by a clinician blind to treatment allocation at baseline, 13, 26 and 52 weeks 5. Lesion accrual is measured using MRI at baseline and 52 weeks 6. Health-related quality of life is measured with the DEMQOL-Proxy at baseline, 13, 26 and 52 weeks 7. Activities of daily living are measured using the Disability Assessment for dementia (DAD) Scale at baseline, 13, 26 and 52 weeks 8. Non-cognitive dementia symptoms are measured using the Neuropsychiatric Inventory (NPI) at baseline, 13, 26 and 52 weeks 9. Change in care-giver burden is measured using the GHQ-12, and care-giver health-related quality of life measured with the EQ-5D-5L at baseline, 13, 26 and 52 weeks | — |
Countries
United Kingdom
Contacts
Public ContactOlga Borejko
Outcome results
None listed