Towards Onset Prevention of COGnition decline in adults with Down syndrome (the TOP-COG study)

Not Applicable

Completed

• Conditions: Dementia in people with Down syndrome; Mental and Behavioural Disorders; Dementia in other diseases classified elsewhere

• Registration Number: ISRCTN67338640
• Lead Sponsor: HS Greater Glasgow and Clyde (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Down syndrome
2. Aged 50 years or over

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The numbers screened and recruited each month over a 6-month recruitment period