Functional DisabilityNCT07224347
Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)
An observational study of Functional Disability and Dementia, run by Anne Murray at 36 sites in 2 countries.
Trial summary
ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and phone calls. 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
- How many people
- 19,114 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 15 Jul 2019to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 United States and Australia. * African American and Hispanic persons age 65 or older in the U.S. * 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
36 sites in 2 countries.
36 sites in 2 countries
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48109
Morehouse School of Medicine
Atlanta, Georgia, 30310
Emory/ Atlanta VAMC
Atlanta, Georgia, 30322
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
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
University of Texas Medical Branch
Galveston, Texas, 77555
Wake Forest University Baptist Medical Center
Greensboro, North Carolina, 27408
The Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
Regional Academic Health Center
Harlingen, Texas, 78550
University of Iowa
Iowa City, Iowa, 52242
University of Tennessee Health Science Center
Memphis, Tennessee, 38105
HealthPartners Research Institute
Minneapolis, Minnesota, 55425
Kent County Memorial Hospital
Pawtucket, Rhode Island, 02860
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
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
About this study
ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants. 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-XT is a longitudinal, observational follow-on study of ASPREE participants.
The methodology of ASPREE-XT is based closely on ASPREE [ASPREE investigator group, 2013; www.aspree.org; McNeil et al. 2017]. Clinical, neurocognitive and physical function measurements, questionnaires for mood, quality of life, physical ability and collection of personal health, demographic and lifestyle details are the same in ASPREE-XT as those conducted and described for ASPREE.
Since ASPREE-XT is an observational study, the endpoints for ASPREE will be collected and adjudicated in a similar way for ASPREE-XT but will be referred to as ASPREE-XT Outcomes. These will not be divided into primary and secondary endpoints.
In 2018, participants were invited to enroll in ASPREE-XT. At the first ASPREE-XT study visit, or via mail, they were provided with an information sheet and consent form for the study Participants who wish to only be contacted by phone were provided with information and a consent form by mail with health and other study data collected by phone call.
- Conditions
- Functional Disability, Dementia, Heart Disease, Stroke, Cancer, Bleeding
- 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, Frailty, Community-Dwelling, Older Adult
- Medical subject headings
- Dementia, Heart Diseases, Stroke, Neoplasms, Hemorrhage, Depression, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | 100 mg enteric-coated aspirin | |
| Placebo | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause or incident dementia or permanent physical disability.
These categories of disability are defined, respectively, as a) all-cause mortality, b) the assessment of dementia by DSM-IV criteria or c) the onset of 'a lot of difficulty' or 'inability' to perform independently, any one of 6 Katz ADLs.
Measured: Planned 5-year time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start15 Jul 2019
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Anne Murray
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Bayer, Monash University, Berman Center for Outcomes and Clinical Research, National Institute on Aging (NIA), National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Anne Murray, Hennepin Healthcare Research Institute
- Investigators
- Anne Murray, MD, MSc, Principal investigator, Berman Center for Outcomes and Clinical ResearchJohn McNeil, MBBS, PHD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224347
- Sponsor's protocol ID
- 201904807
- Other IDs
- U19AG062682
- Status last verified
- Jan 2025
- First submitted
- 31 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)
- ClinicalTrials.gov ID
- NCT07224347
- Acronym / sponsor ID
- 201904807
- Conditions
- Functional Disability, Dementia, Heart Disease, Stroke, Cancer, Bleeding
- Keywords
- Aspirin, Prevention, Healthy, Over 70 years old, ASPREE, Aspirin in Reducing Events in the Elderly, Australia, Functional Disability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 19,114 participants (actual)
- Lead sponsor
- Anne MurrayUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Bayer, Monash University, Berman Center for Outcomes and Clinical Research, National Institute on Aging (NIA), National Cancer Institute (NCI)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants. 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.
Detailed description
ASPREE-XT is a longitudinal, observational follow-on study of ASPREE participants.
The methodology of ASPREE-XT is based closely on ASPREE [ASPREE investigator group, 2013; www.aspree.org; McNeil et al. 2017]. Clinical, neurocognitive and physical function measurements, questionnaires for mood, quality of life, physical ability and collection of personal health, demographic and lifestyle details are the same in ASPREE-XT as those conducted and described for ASPREE.
Since ASPREE-XT is an observational study, the endpoints for ASPREE will be collected and adjudicated in a similar way for ASPREE-XT but will be referred to as ASPREE-XT Outcomes. These will not be divided into primary and secondary endpoints.
In 2018, participants were invited to enroll in ASPREE-XT. At the first ASPREE-XT study visit, or via mail, they were provided with an information sheet and consent form for the study Participants who wish to only be contacted by phone were provided with information and a consent form by mail with health and other study data collected by phone call.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | – | –100 mg enteric-coated aspirin |
| Placebo | – | –Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Men and women recruited from the United States and Australia. * African American and Hispanic persons age 65 or older in the U.S. * 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death from any cause or incident dementia or permanent physical disability.
Time frame: Planned 5-year time frame
These categories of disability are defined, respectively, as a) all-cause mortality, b) the assessment of dementia by DSM-IV criteria or c) the onset of 'a lot of difficulty' or 'inability' to perform independently, any one of 6 Katz ADLs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Murray, MD, MSc principal investigator
Berman Center for Outcomes and Clinical Research
John McNeil, MBBS, PHD principal investigator
Monash University
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Disability and Dementia, run by Anne Murray at 36 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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?
This study is still under way. Results are not available in the source record yet.
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?
Death from any cause or incident dementia or permanent physical disability. (time frame: Planned 5-year time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2025.