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22 May 2012
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| Towards Onset Prevention of COGnition decline in adults with Down syndrome (the TOP-COG study) |
| ISRCTN | ISRCTN67338640 |
| ClinicalTrials.gov identifier | |
| Public title | Towards Onset Prevention of COGnition decline in adults with Down syndrome (the TOP-COG study) |
| Scientific title | Towards Onset Prevention of COGnition decline in adults with Down syndrome (the TOP-COG study): a double blind randomised placebo controlled trial |
| Acronym | TOP-COG |
| Serial number at source | Sponsors protocol number: GN09CP301 |
| Study hypothesis |
It is feasable to study and collect pilot data on whether simvastatin is effective in the primary prevention of dementia in older adults with Down syndrome
As of 22/05/2012, the following changes have been made on the trial record. Anticipated start date has been amended from 01/01/2012 to 01/04/2012. Anticipated end date has been amended from 31/12/2013 to 31/03/2014. |
| Lay summary | Lay summary under review |
| Ethics approval | Scotland A REC approved on 05.07.11, amendment approved on 06.10.11, Ref: 11/AL/0200 |
| Study design | Double blind randomised placebo controlled trial with a nested qualitative study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Dementia in people with Down syndrome |
| Participants - inclusion criteria |
1. Down syndrome
2. Aged 50 years or over |
| Participants - 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) |
| Anticipated start date | 01/04/2012 |
| Anticipated end date | 31/03/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 |
| 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 then allocated to one of two groups. This is so we can compare the outcomes of taking simvastatin against taking a placebo. To try to make sure the groups are the same to start with, each person is put into a group by chance. There is an equal chance of getting into either of the two groups. For the following year, the doctor will prescribe people in one group a simvastatin capsule every night (40mg), and the other group a placebo capsule every night. Both groups also continue to receive all their health care and supports as per usual. 6-12 weeks after starting, we will visit to make sure there are no side effects. After a year of taking the medication, the researcher will visit again to ask about health and supports, and request an optional blood test. We can then check the differences between the two groups.
The study will assess how many people take part, and factors affecting participation. It will determine the most sensitive tests and puzzles to detect early memory changes. Differences between the two groups in memory changes over a year will be measured, to gauge the number who should be recruited in the future large study. A sub-study will also seek the views of about 10 people regarding taking part in the trial. We will also ask participants if we may store their blood samples for future use, and link to their health records in future. |
| Primary outcome measure(s) | The numbers screened and recruited each month over a 6 month recruitment period |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Chief Scientist Office of the Scottish Executive Health Department (UK) (Reference: CZH/4/626) |
| Trial website | |
| Publications | |
| Contact name | Prof Sally-Ann Cooper |
| Address |
Institute of Health and Wellbeing
University of Glasgow Mental Health and Wellbeing Gartnavel Royal Hospital Administrative Building 1055, Great Western Road |
| City/town | Glasgow |
| Zip/Postcode | G12 0XH |
| Country | United Kingdom |
| Tel | +44 (0)141 211 0690 |
| Sally-Ann.Cooper@glasgow.ac.uk | |
| Sponsor | NHS Greater Glasgow and Clyde (UK) |
| Address |
1st Floor
R&D Central Office The Tennent Institute Western Infirmary 38 Church Street |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Tel | +44 (0)141 211 6208 |
| Erica.Packard@ggc.scot.nhs.uk | |
| Date applied | 07/10/2011 |
| Last edited | 22/05/2012 |
| Date ISRCTN assigned | 17/11/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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