Christian J. Camargo, S. Merritt, M. Modjeski, D. S. Counotte, K. Fernández McInerney
{"title":"口服多种营养素治疗干预减少衰老对认知的影响:反应试验研究设计","authors":"Christian J. Camargo, S. Merritt, M. Modjeski, D. S. Counotte, K. Fernández McInerney","doi":"10.14283/jpad.2023.81","DOIUrl":null,"url":null,"abstract":"Clinical benefits have been reported with a specific multinutrient intervention (Souvenaid) in Alzheimer’s disease and mild cognitive impairment due to Alzheimer’s disease. The effects of Souvenaid in age-related cognitive decline are not established. To assess the feasibility of using virtual assessments to study the effects of a multinutrient on cognitive ageing. This is a randomized, double-blind, placebo-controlled, parallel group virtual pilot trial performed over 6 months in a single-centre. Participants are randomly allocated (1:1) to receive the specific multinutrient (Souvenaid) or an isocaloric, same tasting, placebo. Trial visits are done virtually using secure online video communication. English or Spanish speaking people aged 55–89 years from all ethnic groups and considered to have age-related cognitive decline are eligible. Neuropyschological tests are done at baseline and after 6 months of intervention. Participants are contacted monthly by telephone to monitor safety, assess motivation and promote compliance. The primary outcome is feasibility determined by assessing recruitment rate, recruitment time, adherence rate and retention rate. A comprehensive set of neuropyschological measures will provide a broad assessment of cognitive function, including verbal memory, processing speed, and attention and executive function. Self-reported questionnaires are used to assess quality of life. This pilot trial will provide data to guide inform selection of participants and outcome measures in future studies in age-related cognitive decline.","PeriodicalId":48606,"journal":{"name":"Jpad-Journal of Prevention of Alzheimers Disease","volume":null,"pages":null},"PeriodicalIF":8.5000,"publicationDate":"2023-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Reducing the Effects of Ageing on Cognition with Therapeutic Intervention of an Oral Multi-Nutrient: The REACTION Pilot Trial Study Design\",\"authors\":\"Christian J. Camargo, S. Merritt, M. Modjeski, D. S. Counotte, K. Fernández McInerney\",\"doi\":\"10.14283/jpad.2023.81\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Clinical benefits have been reported with a specific multinutrient intervention (Souvenaid) in Alzheimer’s disease and mild cognitive impairment due to Alzheimer’s disease. The effects of Souvenaid in age-related cognitive decline are not established. To assess the feasibility of using virtual assessments to study the effects of a multinutrient on cognitive ageing. This is a randomized, double-blind, placebo-controlled, parallel group virtual pilot trial performed over 6 months in a single-centre. Participants are randomly allocated (1:1) to receive the specific multinutrient (Souvenaid) or an isocaloric, same tasting, placebo. Trial visits are done virtually using secure online video communication. English or Spanish speaking people aged 55–89 years from all ethnic groups and considered to have age-related cognitive decline are eligible. Neuropyschological tests are done at baseline and after 6 months of intervention. Participants are contacted monthly by telephone to monitor safety, assess motivation and promote compliance. The primary outcome is feasibility determined by assessing recruitment rate, recruitment time, adherence rate and retention rate. 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This pilot trial will provide data to guide inform selection of participants and outcome measures in future studies in age-related cognitive decline.\",\"PeriodicalId\":48606,\"journal\":{\"name\":\"Jpad-Journal of Prevention of Alzheimers Disease\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":8.5000,\"publicationDate\":\"2023-06-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Jpad-Journal of Prevention of Alzheimers Disease\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.14283/jpad.2023.81\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Jpad-Journal of Prevention of Alzheimers Disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.14283/jpad.2023.81","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Reducing the Effects of Ageing on Cognition with Therapeutic Intervention of an Oral Multi-Nutrient: The REACTION Pilot Trial Study Design
Clinical benefits have been reported with a specific multinutrient intervention (Souvenaid) in Alzheimer’s disease and mild cognitive impairment due to Alzheimer’s disease. The effects of Souvenaid in age-related cognitive decline are not established. To assess the feasibility of using virtual assessments to study the effects of a multinutrient on cognitive ageing. This is a randomized, double-blind, placebo-controlled, parallel group virtual pilot trial performed over 6 months in a single-centre. Participants are randomly allocated (1:1) to receive the specific multinutrient (Souvenaid) or an isocaloric, same tasting, placebo. Trial visits are done virtually using secure online video communication. English or Spanish speaking people aged 55–89 years from all ethnic groups and considered to have age-related cognitive decline are eligible. Neuropyschological tests are done at baseline and after 6 months of intervention. Participants are contacted monthly by telephone to monitor safety, assess motivation and promote compliance. The primary outcome is feasibility determined by assessing recruitment rate, recruitment time, adherence rate and retention rate. A comprehensive set of neuropyschological measures will provide a broad assessment of cognitive function, including verbal memory, processing speed, and attention and executive function. Self-reported questionnaires are used to assess quality of life. This pilot trial will provide data to guide inform selection of participants and outcome measures in future studies in age-related cognitive decline.
期刊介绍:
The JPAD « Journal of Prevention of Alzheimer’Disease » will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including : neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.
JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.