Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline.
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-...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Journal Article |
| Language: | English |
| Published: |
2020
|
| Subjects: | |
| Online Access: | http://purl.org/au-research/grants/nhmrc/1136372 http://hdl.handle.net/20.500.11937/80070 |
| _version_ | 1848764155007336448 |
|---|---|
| author | Ryan, Joanne Storey, Elsdon Murray, Anne M Woods, Robyn L Wolfe, Rory Reid, Christopher Nelson, Mark R Chong, Trevor TJ Williamson, Jeff D Ward, Stephanie A Lockery, Jessica E Orchard, Suzanne G Trevaks, Ruth Kirpach, Brenda Newman, Anne B Ernst, Michael E McNeil, John J Shah, Raj C ASPREE Investigator Group |
| author_facet | Ryan, Joanne Storey, Elsdon Murray, Anne M Woods, Robyn L Wolfe, Rory Reid, Christopher Nelson, Mark R Chong, Trevor TJ Williamson, Jeff D Ward, Stephanie A Lockery, Jessica E Orchard, Suzanne G Trevaks, Ruth Kirpach, Brenda Newman, Anne B Ernst, Michael E McNeil, John J Shah, Raj C ASPREE Investigator Group |
| author_sort | Ryan, Joanne |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T11:14:51Z |
| format | Journal Article |
| id | curtin-20.500.11937-80070 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| language | eng |
| last_indexed | 2025-11-14T11:14:51Z |
| publishDate | 2020 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-800702024-01-18T08:38:30Z Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. Ryan, Joanne Storey, Elsdon Murray, Anne M Woods, Robyn L Wolfe, Rory Reid, Christopher Nelson, Mark R Chong, Trevor TJ Williamson, Jeff D Ward, Stephanie A Lockery, Jessica E Orchard, Suzanne G Trevaks, Ruth Kirpach, Brenda Newman, Anne B Ernst, Michael E McNeil, John J Shah, Raj C ASPREE Investigator Group ASPREE Investigator Group 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. 2020 Journal Article http://hdl.handle.net/20.500.11937/80070 10.1212/WNL.0000000000009277 eng http://purl.org/au-research/grants/nhmrc/1136372 http://purl.org/au-research/grants/nhmrc/1135727 http://purl.org/au-research/grants/nhmrc/1127060 http://purl.org/au-research/grants/nhmrc/334047 unknown |
| spellingShingle | ASPREE Investigator Group Ryan, Joanne Storey, Elsdon Murray, Anne M Woods, Robyn L Wolfe, Rory Reid, Christopher Nelson, Mark R Chong, Trevor TJ Williamson, Jeff D Ward, Stephanie A Lockery, Jessica E Orchard, Suzanne G Trevaks, Ruth Kirpach, Brenda Newman, Anne B Ernst, Michael E McNeil, John J Shah, Raj C ASPREE Investigator Group Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. |
| title | Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. |
| title_full | Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. |
| title_fullStr | Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. |
| title_full_unstemmed | Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. |
| title_short | Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. |
| title_sort | randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. |
| topic | ASPREE Investigator Group |
| url | http://purl.org/au-research/grants/nhmrc/1136372 http://purl.org/au-research/grants/nhmrc/1136372 http://purl.org/au-research/grants/nhmrc/1136372 http://purl.org/au-research/grants/nhmrc/1136372 http://hdl.handle.net/20.500.11937/80070 |