Dementia in people with Down syndrome Mental and Behavioural Disorders Dementia in other diseases classified elsewhere
Conditions
Interventions
A researcher will visit participants at home and ask questions about their health and supports. She/he will ask for a blood test, or a thumb pin-prick sample and saliva collection. Participants are th
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Down syndrome 2. Aged 50 years or over
Exclusion criteria
Exclusion criteria: 1. No consent obtained 2. Unable to comply with the protocol, including providing blood or saliva for baseline apolipoprotein E e4 polymorphism (APO E e4) measurement, and venous or capillary blood for cholesterol measurement 3. Dementia at baseline (as the study is investigating primary prevention) 4. Diabetes (as this is an indication for a prescription of a statin) 5. Clinically evident atherosclerotic disease (as this is an indication for a prescription of a statin) 6. Being at risk for cardiovascular disease (as this is an indication for a prescription of a statin) 7. Liver disease 8. Chronic renal insufficiency 9. Being prescribed a statin or medicines that are listed as contraindicated with simvastatin in its summary of product characteristics: 9.1. Statin 9.2. Fibrates 9.3. Nicotinic acid 9.4. Cyclosporine 9.5. Triazole antifungals, including fluconazole, itraconazole, posaconazole 9.6. Ketoconazole 9.7. Macrolide antibiotics, including erythromycin, clarithromycin, telithromycin 9.8. Danazol 9.9. Fusidic acid 9.10. Human immunodeficiency virus (HIV) protease inhibitors, e.g. nelfinavir 9.11. Nefazodone 9.12. Verapamil 9.13. Amiodarone 9.14. Warfarin 10. Having previously had a statin serious adverse reactions (SAR) 11. Unable or unwilling to avoid consumption of grapefruit juice 12. Excessive alcohol use (>21 units/week for men, or >14 units/week for women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The numbers screened and recruited each month over a 6-month recruitment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure(s): 1. Memory for objects from the Neuropsychological Assessment of Dementia In Intellectual Disabilities (NADIID) battery 2. Selective Attention Cancellation Task 3. Pattern Recognition Memory from the Cambridge Neuropsychological Test Automated Battery (CANTAB) 4. The cats and dogs test 5. Tower of London Test 6. Cued Recall Test 7. Category fluency 8. Story recall (adapted from the Rivermead Behavioural Memory Test for Children) 9. Adaptive Behavior Scale (AAID-ABS) 10. Townsend scale 11. EQ-5D 12. Client Services Receipt Inventory (CSRI) 13. Carer General Health Questionnaire-12 (GHQ-12) 14. Blood AB40 / AB42 level Previous secondary outcome measure(s): 1. Memory for objects from the Neuropsychological Assessment of Dementia In Intellectual Disabilities (NADIID) battery 2. Selective Attention Cancellation Task 3. Pattern Recognition Memory from the Cambridge Neuropsychological Test Automated Battery (CANTAB) 4. Delayed Matching to Sample from the CANTAB 5. Tower of London Test 6. Cued Recall Test 7. Category fluency 8. Story recall (adapted from the Rivermead Behavioural Memory Test for Children) 9. Adaptive Behavior Scale (AAID-ABS) 10. Townsend scale 11. EQ-5D 12. Client Services Receipt Inventory (CSRI) 13. Carer General Health Questionnaire-12 (GHQ-12) 14. Blood AB40/AB42 level | — |
Countries
United Kingdom
Outcome results
None listed