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Functional DisabilityASPREENCT01038583

Aspirin in Reducing Events in the Elderly

An observational study of Functional Disability and Dementia, run by Hennepin Healthcare Research Institute at 47 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants [ASPREE Investigator Group, 2013; www.aspree.org; McNeil et al 2017]. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Functional Disability, Dementia, Heart Disease
What is being tested?
100 mg enteric-coated aspirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19,114 participants
Where
47 sitesin 2 countries
Study dates
Jan 2010to Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Men and women recruited from the US and Australia. * African American and Hispanic persons age 65 or older in the US * Any person from another ethnic minority group and Caucasian persons age 70 or older * Willing and able to provide informed consent, and willing to accept the study requirements

Who may be able to join

  • Men and women
  • African American and Hispanic persons age 65 or older
  • Any person from another ethnic minority group and Caucasian persons age 70 or older
  • Willing and able to provide informed consent, and willing to accept the study requirements

Who cannot join

  • A history of a diagnosed cardiovascular event
  • A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease
  • A current or recurrent condition with a high risk of major bleeding, ex: cerebral aneurysm
  • Anemia
  • Absolute contraindication or allergy to aspirin
  • Current participation in a clinical trial
Show all 11Show fewer
  • Current continuous use of aspirin or other anti-platelet drug or anticoagulant for secondary prevention. People with previous use of aspirin for primary prevention may enter the trial, provided they agree to cease existing use of aspirin and understand that they may be subsequently randomly allocated to low dose aspirin or placebo.
  • A systolic blood pressure ≥180 mmHg and / or a diastolic blood pressure ≥105 mmHg
  • A history of dementia
  • Severe difficulty or an inability to perform any one of the 6 Katz ADLs
  • Non-compliance to taking pill

Trial locations and contacts

47 sites in 2 countries.

47 sites in 2 countries

United States33 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Emory/ Atlanta VAMC

    Atlanta, Georgia, 30322

  • Georgia Health Sciences University

    Augusta, Georgia, 30912

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Mary Bird Perkins Our Lady of the Lake Cancer Center

    Baton Rouge, Louisiana, 70809

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Rush Alzheimer's Disease Center

    Chicago, Illinois, 60612

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Central Jersey Medical Center

    Elizabeth, New Jersey, 07202

  • University of Florida Department of Aging and Geriatrics

    Gainesville, Florida, 32611

  • University of TX Medical Branch

    Galveston, Texas, 77555

  • Wake Forest University Baptist Medical Center

    Greensboro, North Carolina, 27408

  • The Brody School of Medicine at ECU

    Greenville, North Carolina, 27834

  • Regional Academic Health Center

    Harlingen, Texas, 78550

  • University of Iowa

    Iowa City, Iowa, 52242

  • Kansas University Medical Center

    Kansas City, Kansas, 66106

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38105

  • Winthrop University Hospital

    Mineola, New York, 11501

  • HealthPartners Research Institute

    Minneapolis, Minnesota, 55425

  • LSU Health Sciences- New Orleans

    New Orleans, Louisiana, 70112

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • Detroit Clinical Research Center

    Novi, Michigan, 48377

  • Palo Alto Medical Foundation Research Institute

    Palo Alto, California, 94301

  • Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island, 02860

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh Health Sciences Research Center

    Pittsburgh, Pennsylvania, 15260

  • Phalen Village Clinic

    Saint Paul, Minnesota, 55106

  • UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • LSU Health Sciences- Shreveport

    Shreveport, Louisiana, 71130

  • Howard University

    Washington D.C., District of Columbia, 20060

Other trials in United States

Australia14 sites

  • Discipline of General Practice, School of Population Health, University of Adelaide

    Adelaide, South Australia, 5005

  • Bendigo Regional Clinical School

    Bendigo, Victoria, 3550

  • University of Tasmania Rural Clinical School

    Burnie, Tasmania, 7320

  • Clinical Trials Unit, The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Geelong Hospital

    Geelong, Victoria, 3220

  • The Menzies Institute for Medical Research, University of Tasmania

    Hobart, Tasmania, 7000

  • University of Tasmania Newnham Campus

    Launceston, Tasmania, 7250

  • Monash Mildura Regional Clinical School

    Mildura, Victoria, 3500

  • Greater Green Triangle University

    Mount Gambier, South Australia, 5290

  • University of Ballarat

    Mount Helen, Victoria, 3350

  • Monash Gippsland Regional Clinical School

    Traralgon, Victoria, 3844

  • The South West Alliance of Rural Health (SWARH)

    Warrnambool, Victoria, 3280

  • Gateway Community Health

    Wodonga, Victoria, 3690

  • Illawarra Health and Medical Research Institute, University of Wollongong

    Wollongong, New South Wales, 2522

Other trials in Australia

About this study

ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants [ASPREE Investigator Group, 2013; www.aspree.org; McNeil et al 2017]. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and phone calls. An observational follow-up phase (ASPREE-XT), began in January, 2018. This will enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastases and mortality. In addition to monitoring the incidence of malignancy within the ASPREE cohort, the opportunity will be taken to observe any other residual effects of aspirin on the endpoints being monitored in the cohort. Continuity of contact with study participants is the key to retention of the cohort for any ongoing or future studies.

Read the detailed description

ASPREE BACKGROUND:

ASPREE (ASPirin in Reducing Events in the Elderly) is a joint US/Australian research project aiming to determine whether low-dose aspirin increases healthy life-span, defined as survival free of dementia and disability. ASPREE began in 2010 and completed recruitment in 2014. It is a randomized, double-blind, placebo-controlled, primary prevention trial of daily 100 mg of aspirin in a population of healthy older people in the United States (US) and Australia with a period of treatment averaging 4.5 years. ASPREE's primary outcome is length of survival free of dementia and disability and has secondary outcomes encompassing the major health issues related to aging. The trial involving 19,114 persons aged 70 and above (65 years and above for US minorities) is distinctive for its large size, methodological rigor and high participant retention rate in both countries.

ASPREE UNIQUE ASPECTS:

  1. It is the first large scale trial to incorporate dementia-free and disability-free survival as a primary outcome. This is now recognized as an appropriate goal of treatment in a primary prevention population of this age group. Within a clinical trial context disability-free survival incorporates an estimate of the overall benefits and risks of aspirin in a single outcome measure.
  2. It is one of the first primary prevention trials of aspirin to include cancer incidence, metastases or mortality as a pre-specified endpoint. Recent meta-analyses [Rothwell et al 2010, 2011, 2012] suggests that aspirin has a significant chemopreventive effect becoming evident after a period of 4+ years of aspirin treatment, but questions remain about the magnitude of benefit, and whether it applies to treatment of all cancers and to older people.
  3. It will provide information about the impact of aspirin on a range of other conditions (e.g, dementia, CVD, stroke, depression, bleeding) where aspirin has been claimed to have benefit (or risks).

The intervention phase of the trial ended in June 2017 after the NIA determined that it was highly unlikely that aspirin would show a benefit on the overall primary outcome within the planned 5-year time frame. The study is now entering a data cleaning and analysis phase and it is anticipated that the primary results were published in September 2018.

Being tested
100 mg enteric-coated aspirin, Placebo
Keywords
Aspirin, Prevention, Healthy, Over 70 years old, ASPREE, Aspirin in Reducing Events in the Elderly, Australia, Functional disability, Dementia, Heart Disease/ Stroke, Cancer, Bleeding
Medical subject headings
Dementia, Heart Diseases, Stroke, Neoplasms, Hemorrhage, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 100 mg enteric-coated aspirinDrug

    100 mg enteric-coated aspirin, taken daily

  • PlaceboDrug

    100 mg enteric-coated placebo

Study groups in NCT01038583
Study groupRoleWhat they receive
Aspirin100 mg enteric-coated aspirin
Receives: Drug: 100 mg enteric-coated aspirin
PlaceboPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is death from any cause or incident, dementia or persistent physical disability.

    Dementia will be diagnosed based on DSM-IV criteria. Significant physical disability will be defined as a confirmed, and persisting for at least 6 months, self-report of 'a lot of difficulty', or 'inability to perform independently' any one of the 6 Katz basic Activities of Daily Living (ADLs).75

    Measured: every 6 months

Secondary outcomes (8)

  1. All-cause mortality

    Measured: every 6 months

  2. Fatal and non fatal cardiovascular events including a) coronary heart disease death, b) non-fatal MI, c) fatal and non-fatal stroke and d) any hospitalization for heart failure

    Measured: every 6 months

  3. Fatal and non-fatal cancer, excluding non-melanoma skin cancer

    Measured: every 6 months

  4. Dementia

    Measured: every 6 months

  5. Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)

    Measured: every 6 months

  6. Physical disability

    Measured: every 6 months

  7. Major hemorrhagic events

    Measured: every 6 months

  8. Depression

    Measured: Annually

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2017
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
19,114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01038583
Sponsor's protocol ID
HSR#09-3029
Other IDs
3U01AG029824-07S2
Acronym
ASPREE
Status last verified
Apr 2021
First submitted
21 Dec 2009
Last updated
5 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Working with ASPREE - for Data Access requests Monitored secure portal - development underway

Publications

  • Barker AL, McNeil JJ, Seeman E, Ward SA, Sanders KM, Khosla S, Cumming RG, Pasco JA, Bohensky MA, Ebeling PR, Woods RL, Lockery JE, Wolfe R, Talevski J; ASPREE Investigator Group. A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy. Inj Prev. 2016 Aug;22(4):297-301. doi: 10.1136/injuryprev-2015-041655. Epub 2015 May 21.

    PubMed 26002770

  • ASPREE Investigator Group. Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial. Contemp Clin Trials. 2013 Nov;36(2):555-64. doi: 10.1016/j.cct.2013.09.014. Epub 2013 Oct 7.

    PubMed 24113028

  • Zhou Z, Yu C, Lacaze P, Wolfe R, Tonkin AM, Zhu C, Woods RL, Zheng J, Neumann JT, Nelson MR, Tran C, Beilin L, Tian F, Qiu P, Ryan J. Identifying Risk-De-Escalating Markers in PREVENT-Defined Intermediate-Risk Older Adults: Insights From ASPREE. Circ Popul Health Outcomes. 2026 Jul 2:e013687. doi: 10.1161/CIRCOUTCOMES.126.013687. Online ahead of print.

    PubMed 42389765

  • Yu C, Hussain SM, Fransquet PD, Tran C, Tonkin AM, Nelson MR, Reid CM, Neumann JT, Williamson JD, Eaton CB, Hand P, Donnan GA, Brodtmann A, Cloud GC, McNeil JJ, Lacaze P. Polygenic Risk Identifies Older Adults Who May Benefit From Aspirin for the Primary Prevention of Ischemic Stroke. Stroke. 2026 Jul;57(7):2098-2107. doi: 10.1161/STROKEAHA.125.054979. Epub 2026 May 8.

    PubMed 42100829

  • Robb C, Carr PR, Ball J, Polekhina G, Clayton-Chubb D, George ES, Fitzpatrick J, Beilin LJ, Newman AB, Owen A, Orchard SG, Tran C, Ryan J, McNeil JJ. Association of Combined Lifestyle Behaviors With Healthspan in Older Adults. J Am Geriatr Soc. 2026 Jun;74(6):1614-1625. doi: 10.1111/jgs.70426. Epub 2026 May 7.

    PubMed 42095703

  • Abhayaratna WP, Reid CM, Webb KL, Wolfe R, Trevaks RE, Robman L, Ward SA, Law M, Sinclair B, Kolbe S, Budge MM, Wong TY, Tonkin A, McNeil JJ, Storey E, Woods RL. The effects of daily low-dose aspirin on white matter hyperintensity lesions and retinal vascular calibre in healthy older adults: the ENVIS-ion exploratory neuroimaging substudy of the ASPREE randomised clinical trial. Lancet Healthy Longev. 2026 Feb;7(2):100815. doi: 10.1016/j.lanhl.2025.100815. Epub 2026 Feb 14.

    PubMed 41698380

  • McQuilten ZK, Thao LTP, Bick AG, Byars S, Chan AT, Ford L, Leichter A, McNeil JJ, Murray AM, Murphy AJ, Orchard SG, Phung J, Ramshaw HS, Singh J, Tonkin AM, Umar A, Wolfe R, Wood EM, Woods RL, Lacaze P, Curtis DJ. Clonal Hematopoiesis and Cardiovascular Disease and Bleeding Risk and the Effectiveness of Aspirin. JAMA Cardiol. 2025 Dec 1;10(12):1257-1266. doi: 10.1001/jamacardio.2025.3756.

    PubMed 41091476

  • Thao LTP, Nguyen TL, Singh J, Byars SG, Bick AG, Ford L, Gibbs P, McNeil JJ, Murray AM, Orchard SG, Phung J, Umar A, Wood EM, Woods RL, Lacaze P, Chan AT, Curtis DJ, McQuilten ZK, Wolfe R. Low-Dose Aspirin for Individualized Cancer Prevention in Older Adults: A Secondary Analysis of the ASPREE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1348-1355. doi: 10.1001/jamaoncol.2025.3593.

    PubMed 40996732

  • Sheets KM, Webb KL, Woods RL, Orchard SG, Beilin L, Fravel MA, Reid CM, Polkinghorne KR, Wolfe R, Zhou Z, Ryan J, Murray AM, Ernst ME. Long-Term Blood Pressure Variability and Physical Performance in Older Adults. J Clin Hypertens (Greenwich). 2025 Sep;27(9):e70139. doi: 10.1111/jch.70139.

    PubMed 40960215

  • Sultana F, Islam RM, Davis SR. Associations between declining testosterone concentrations and cognitive performance in community-dwelling older Australian women: a prospective cohort study. Climacteric. 2026 Feb;29(1):46-52. doi: 10.1080/13697137.2025.2539854. Epub 2025 Aug 14.

    PubMed 40810327

  • Brodtmann A, Cheng N, Werden E, Neumann J, Robb C, Fitzgerald SM, Wolfe R, Tonkin AM, Orchard SG, Ryan J, Woods RL, Gao C, McNeil JJ. Cognitive trajectories and incident atrial fibrillation in the ASPREE cohort. medRxiv [Preprint]. 2025 Aug 1:2025.08.01.25332579. doi: 10.1101/2025.08.01.25332579.

    PubMed 40766137

  • Clayton-Chubb D, Majeed A, Commins I, Woods RL, Chan AT, Ryan J, Neumann JT, Schneider HG, Tonkin AM, Nelson MR, Fitzgerald SM, Orchard SG, Lubel JS, Sikavi DR, Tran C, Hodge AD, McNeil JJ, Kemp WW, Roberts SK. Prevalence and outcomes of steatotic liver disease subtypes in older adults. Hepatol Commun. 2025 Jun 30;9(7):e0756. doi: 10.1097/HC9.0000000000000756. eCollection 2025 Jul 1.

    PubMed 40576655

  • Fravel MA, Ernst ME, Woods RL, Orchard SG, Ganjali S, Wetmore JB, Reid C, Ryan J, Polkinghorne KR, Wolfe R, Nelson MR, Zoungas S, Zhou Z. Performance of the American Heart Association PREVENT Cardiovascular Risk Equations in Older Adults. Circ Cardiovasc Qual Outcomes. 2025 Jun;18(6):e011719. doi: 10.1161/CIRCOUTCOMES.124.011719. Epub 2025 Apr 28.

    PubMed 40289804

  • Espinoza SE, Broder JC, Wolfe R, Ernst ME, Shah RC, Orchard SG, Woods RL, Ryan J, Murray A. Frailty incidence by diabetes treatment regimens in older adults with diabetes mellitus in the ASPirin in Reducing Events in the Elderly Study. Geroscience. 2025 Jun;47(3):5169-5183. doi: 10.1007/s11357-025-01598-6. Epub 2025 Mar 17.

    PubMed 40097879

  • Ward SA, Storey E, Naughton MT, Wolfe R, Hamilton GS, Law M, Kawasaki R, Abhayaratna WP, Webb KL, O'Donoghue FJ, Gasevic D, Stocks NP, Trevaks RE, Robman LD, Kolbe S, Fitzgerald SM, Orchard SG, Wong TY, McNeil JJ, Reid CM, Sinclair B, Woods RL. Obstructive sleep apnea and cerebral small vessel disease in community-based older people: an aspirin in reducing events in the elderly imaging substudy. Sleep. 2025 Feb 10;48(2):zsae204. doi: 10.1093/sleep/zsae204.

    PubMed 39301859

Questions about this trial

What is this clinical trial studying?

An observational study of Functional Disability and Dementia, run by Hennepin Healthcare Research Institute at 47 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is death from any cause or incident, dementia or persistent physical disability. (time frame: every 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01038583, which also lists 65 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.

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