Joanne Ryan1, Elsdon Storey1, Anne M Murray2, Robyn L Woods2, Rory Wolfe2, Christopher M Reid2, Mark R Nelson2, Trevor T J Chong2, Jeff D Williamson2, Stephanie A Ward2, Jessica E Lockery2, Suzanne G Orchard2, Ruth Trevaks2, Brenda Kirpach2, Anne B Newman2, Michael E Ernst2, John J McNeil2, Raj C Shah2. 1. From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL. elsdon.storey@monash.edu joanne.ryan@monash.edu. 2. From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.
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. CLINICALTRIALSGOV IDENTIFIER: NCT01038583.
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. CLINICALTRIALSGOV IDENTIFIER: NCT01038583.
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