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Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline

Ryan, J, Storey, E, Murray, AM, Woods, R, Wolfe, R, Reid, CM, Nelson, MR ORCID: 0000-0001-9941-7161, Chong, TTJ, Williamson, JD, Ward, SA, Lockery, JE, Orchard, SG, Trevaks, R, Kirpach, B, Newman, AB, Ernst, ME, McNeil, JJ and Shah, RC 2020 , 'Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline' , Neurology , pp. 1-12 , doi: 10.1212/WNL.0000000000009277.

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Abstract

Objective:To determine the effect of low-dose aspirin vs placebo on incident all-cause dementia, incident Alzheimer disease (AD), mild cognitive impairment (MCI), and cognitive decline in older individuals.Methods:Aspirin in Reducing Events in the Elderly (ASPREE) was a double-blind, placebo-controlled trial of low-dose aspirin. In the United States and Australia, community-dwelling individuals aged ≥70 years (US minorities ≥65 years) and free of cardiovascular disease, physical disability, and diagnosed dementia were enrolled. Participants were randomized 1:1-100 mg daily aspirin or placebo. The Modified Mini-Mental State Examination, Hopkins Verbal Learning Test-Revised, Symbol Digit Modalities Test, and Controlled Oral Word Association Test assessed cognition at baseline and over follow-up. Additional cognitive testing was performed in participants with suspected dementia ("trigger") based on within-study assessments or clinical history. Dementia was adjudicated according to DSM-IV criteria. National Institute on Aging-Alzheimer's Association criteria were used for AD and MCI subclassification.Results:A total of 19,114 participants were followed over a median 4.7 years and 964 triggered further dementia assessments. There were 575 adjudicated dementia cases, and 41% were classified as clinically probable AD. There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo. Cognitive change over time was similar in the aspirin and placebo groups.Conclusions:There was no evidence that aspirin was effective in reducing risk of dementia, MCI, or cognitive decline. Follow-up of these outcomes after initial exposure is ongoing.Classification of evidence:This study provides Class II evidence that for healthy older individuals, low-dose aspirin does not significantly reduce the incidence of dementia, probable AD, MCI, or cognitive decline.

Item Type: Article
Authors/Creators:Ryan, J and Storey, E and Murray, AM and Woods, R and Wolfe, R and Reid, CM and Nelson, MR and Chong, TTJ and Williamson, JD and Ward, SA and Lockery, JE and Orchard, SG and Trevaks, R and Kirpach, B and Newman, AB and Ernst, ME and McNeil, JJ and Shah, RC
Journal or Publication Title: Neurology
Publisher: Lippincott Williams & Wilkins
ISSN: 0028-3878
DOI / ID Number: 10.1212/WNL.0000000000009277
Copyright Information:

Copyright © 2020 American Academy of Neurology

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