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dc.contributor.authorCooper, Sally-Ann
dc.contributor.authorAdemola, Temitope
dc.contributor.authorCaslake, Muriel
dc.contributor.authorDouglas, Elizabeth
dc.contributor.authorEvans, Jonathan
dc.contributor.authorGreenlaw, Nicola
dc.contributor.authorHaig, Caroline
dc.contributor.authorHassiotis, Angela
dc.contributor.authorJahoda, Andrew
dc.contributor.authorMcConnachie, Alex
dc.contributor.authorMorrison, Jill
dc.contributor.authorRing, Howard
dc.contributor.authorStarr, John
dc.contributor.authorStiles, Ciara
dc.contributor.authorSirisena, Chammy
dc.contributor.authorSullivan, Frank
dc.date.accessioned2017-05-11T15:30:13Z
dc.date.available2017-05-11T15:30:13Z
dc.date.issued2016-07-29
dc.identifier.citationCooper , S-A , Ademola , T , Caslake , M , Douglas , E , Evans , J , Greenlaw , N , Haig , C , Hassiotis , A , Jahoda , A , McConnachie , A , Morrison , J , Ring , H , Starr , J , Stiles , C , Sirisena , C & Sullivan , F 2016 , ' Towards onset prevention of cognition decline in adults with Down syndrome (The TOP-COG study) : a pilot randomised controlled trial ' , Trials , vol. 17 , 370 . https://doi.org/10.1186/s13063-016-1370-9en
dc.identifier.issn1745-6215
dc.identifier.otherPURE: 249968792
dc.identifier.otherPURE UUID: 3e7b5c82-545e-4453-812e-10b133f9e2fe
dc.identifier.otherPubMed: 27473843
dc.identifier.otherPubMedCentral: PMC4966871
dc.identifier.otherScopus: 84979705707
dc.identifier.urihttp://hdl.handle.net/10023/10754
dc.descriptionThis study was funded by the Chief Scientist Office, Scottish Government Health Department (reference: CZH/4/626). JS is funded by the NHS Lothian R&D Directorate.en
dc.description.abstractBackground : Dementia is very common in Down syndrome (trisomy 21) adults. Statins may slow brain amyloid β (Aβ, coded on chromosome 21) deposition and, therefore, delay Alzheimer disease onset. One prospective cohort study with Down syndrome adults found participants on statins had reduced risk of incident dementia, but there are no randomised controlled trials (RCTs) on this issue. Evidence is sparse on the best instruments to detect longitudinal cognitive decline in older Down syndrome adults. Methods : TOP-COG was a feasibility/pilot, double-blind RCT of 12 months simvastatin 40 mg versus placebo for the primary prevention of dementia in Alzheimer disease in Down syndrome adults aged 50 years or older. Group allocation was stratified by age, apolipoprotein E (APOE) ε4 allele status, and cholesterol level. Recruitment was from multiple general community sources over 12 months. Adults with dementia, or simvastatin contraindications, were excluded. Main outcomes were recruitment and retention rates. Cognitive decline was measured with a battery of tests; secondary measures were adaptive behaviour skills, general health, and quality of life. Assessments were conducted pre randomisation and at 12 months post randomisation. Blood Aβ40/Aβ42 levels were investigated as a putative biomarker. Results were analysed on an intention-to-treat basis. A qualitative sub-study was conducted and analysed using the Framework Approach to determine recruitment motivators/barriers, and participation experience. Results : We identified 181 (78 %) of the likely eligible Down syndrome population, and recruited 21 (11.6 %), from an area with a general population size of 3,135,974. Recruitment was highly labour-intensive. Thirteen (62 %) participants completed the full year. Results favoured the simvastatin group. The most appropriate cognitive instrument (regarding ease of completion and detecting change over time) was the Memory for Objects test from the Neuropsychological Assessment of Dementia in Individuals with Intellectual Disabilities battery. Cognitive testing appeared more sensitive than proxy-rated adaptive behaviour, quality of life, or general health scores. Aβ40 levels changed less for the simvastatin group (not statistically significant). People mostly declined to participate because of not wanting to take medication, and not knowing if they would receive simvastatin or placebo. Participants reported enjoying taking part. Conclusion : A full-scale RCT is feasible. It will need 37 % UK population coverage to recruit the required 160 participants. Information/education about the importance of RCT participation is needed for this population.
dc.format.extent16
dc.language.isoeng
dc.relation.ispartofTrialsen
dc.rights© 2016 Cooper et al. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.subjectAlzheimer diseaseen
dc.subjectDementiaen
dc.subjectDown syndromeen
dc.subjectNeuropsychologyen
dc.subjectPrimary preventionen
dc.subjectSimvastatinen
dc.subjectStatinen
dc.subjectRC0321 Neuroscience. Biological psychiatry. Neuropsychiatryen
dc.subjectNDASen
dc.subjectBDCen
dc.subject.lccRC0321en
dc.titleTowards onset prevention of cognition decline in adults with Down syndrome (The TOP-COG study) : a pilot randomised controlled trialen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.identifier.doihttps://doi.org/10.1186/s13063-016-1370-9
dc.description.statusPeer revieweden


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