Independent LivingPhase 4STAREENCT02099123
A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)
A Phase 4 study testing Atorvastatin in people with Independent Living and Disability Free Survival, run by Monash University at 6 sites in Australia.
Trial summary
The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong disability free survival and reduce major cardiovascular events amongst healthy elderly people (≥70 years). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Independent Living, Disability Free Survival, Elderly
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,971 participants
- Where
- 6 sitesAustralia
- Study dates
- Jul 2015to Dec 2025
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women aged ≥70 years living independently in the community
- Willing and able to provide informed consent and accept the study requirements (Note: competent physical ability to participate in the trial is assessed using the KATZ ADL questionnaire)
Who cannot join
- A history of cardiovascular disease (defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, coronary artery angioplasty and/or stenting, coronary artery bypass grafting, carotid stenosis, abdominal aortic aneurysm or heart failure),
- A history of dementia or a 3MS score <78 on screening,
- A history of diabetes,
- Total cholesterol >7.5 mmol/L,
- Moderate or severe chronic kidney disease (persistent proteinuria (Urine albumin:creatinine ratio >30mg/mmol or Urine protein:creatinine ratios >45 mg/mmol)45 and/or eGFR <45ml/min/1.73m2),
- Moderate or severe liver disease (persistent elevations of transaminases of more than 3 times the upper limit of the normal laboratory reference range),
Show all 11Show fewer
- Serious inter-current illness likely to cause death within the next 5 years such as terminal cancer or obstructive airways disease,
- Current participation in a clinical trial,
- Absolute contraindication to statin therapy,
- Current use of statin therapy or other lipid lowering therapy for primary prevention and unwilling to stop therapy,
- Current long term or permanent use of the following cytochrome P450 (CYP) 3A4 inhibitors : Amiodarone, Boceprevir, Cimetidine, Cyclosporin, Danazol, Fosamprenavir, Indinavir, Lopinavir + Ritonavir, Erythromycin, Fluconazole, Itraconazole, Ketoconazole.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
South Australia
Adelaide, Western Australia
Queensland
Brisbane
Tasmania
Hobart, Tasmania
Victoria
Melbourne, Victoria
New South Wales
Newcastle
Western Australia
Perth
About this study
Official title: A Study of STAtins for Reducing Events in the Elderly (STAREE)
The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong disability free survival and reduce major cardiovascular events amongst healthy elderly people (≥70 years).
Read the detailed description
Statin therapy has been shown to reduce the risk of vascular events in younger individuals with manifest atherosclerotic disease or at high risk of vascular events. However, data derived from meta-analyses of existing trials suggests that the efficacy of statins may decline sharply amongst those over 70-75 years of age. Insufficient patients of this age group have been included in major trials to be certain of the benefit. Within this age group part of the benefit of statin therapy may be offset by adverse effects including myopathy, development of diabetes, cancer and cognitive impairment, all of which are more prevalent in the elderly in any event.
The use of statins in the over 70 age group raises fundamental questions about the purpose of preventive drug therapy in this age group. When a preventive agent is used in the context of competing mortality, polypharmacy and a higher incidence of adverse effects its use should be justified by an improvement in quality of life or some other composite measure that demonstrates that the benefit outweighs other factors.
STAREE will determine whether taking daily statin therapy (40 mg atorvastatin) will extend the length of a disability-free life, determined from survival outside permanent residential care, in healthy participants aged 70 years and above.
- Conditions
- Independent Living, Disability Free Survival, Elderly, Healthy
- Being tested
- Atorvastatin, Placebo (for Atorvastatin)
- Keywords
- Survival, Functional Disability, Cardiovascular Disease, Diabetes, Dementia, Cancer
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Dementia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor, , , Cadivast, Caduet, Lorstat, Torvastat, Trovas, Atorachol, Cadatin
Atorvastatin 20 mg tablet
Placebo (for Atorvastatin)Drug
Also called no other names
Inactive pill manufactured to mimic Atorvastatin 20 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Placebo (2 x 20 mg placebo) taken orally once daily Receives: Drug: Placebo (for Atorvastatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability free survival - death or development of dementia or development of persistent physical disability
Defined as survival free of dementia or persistent physical disability (as derived from the endpoints of all-cause mortality, dementia and physical disability)
Measured: Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Major cardiovascular events
Defined as the first occurrence of a cardiovascular death or a non-fatal myocardial infarction or stroke or coronary revascularisation
Measured: Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcomes (16)
A composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke
A composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Cardiovascular death
Fatal cardiovascular events
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Fatal and Non-fatal Mycocardial infarction
Fatal and non-fatal
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Hospitalisations
Hospitalisation reasons and length of stay
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Fatal and Non-fatal Cancer
Fatal and Non-fatal Cancer (excluding non-melanoma skin cancer)
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Other cognitive impairment
Cognitive decline as assessed using cognitive tests excluding depression
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Quality of life measured by the Short Form Health Survey (SF-36)
Quality of life (measured by the Short Form Health Survey (SF-36) administered at every second year of follow-up).
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Cost-effectiveness of statin
Cost-effectiveness of statin
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Fatal and Non-fatal Stroke
Fatal and Non-fatal Stroke can be a) haemorrhagic or b) thromboembolic
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Approved need for permanent residential care
ACAS report
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Dementia
All-cause dementia (COWAT, Stroop test, Trail Making Test, HVLT-R, SDMT, ADAS-Cog, Lurian overlapping figures) or external diagnosis
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Persistent physical disability
KATZ-ADL administered every 6 months or external diagnosis
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
All cause death
All cause death
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Heart failure
Heart failure
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Atrial fibrillation
Atrial fibrillation
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Revascularisation procedure
Revascularisation procedure including coronary revascularisation
Measured: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Independent LivingStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, National Heart Foundation, Australia
- Responsible party
- Principal investigator, Sophia Zoungas, Monash University
- Investigators
- Sophia Zoungas, MBBS, FRACP, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099123
- Sponsor's protocol ID
- NHMRC 1068146
- Acronym
- STAREE
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2014
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On completion of the trial, and after publication of the primary and secondary outcomes of the study, requests for access to de-identified data (to be provided through a secure online environment) may be submitted to the researchers located at the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
Publications
Zoungas S, Wolfe R, Moran C, Nicholls SJ, Cloud GC, Reid CM, Tauonkin AM, Beilin L, Wierzbicki AS, Chong TT, Broder JC, Curtis AJ, Flanagan Z, Hopper I, Ryan J, Spark S, McNeil JJ, Nelson MR; STAREE Investigators. Atorvastatin, Cardiovascular Events, and Disability-free Survival in Older Adults. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2607314. Online ahead of print.
PubMed 42670961Zoungas S, Moran C, Curtis AJ, Spark S, Flanagan Z, Beilin L, Chong TT, Cloud GC, Hopper I, Kost A, McNeil JJ, Nicholls SJ, Reid CM, Ryan J, Tonkin AM, Ward S, Wierzbicki AS, Wolfe R, Zhou Z, Nelson MR; STAREE investigator group. Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability-Free Survival in Older People. J Am Heart Assoc. 2024 Nov 19;13(22):e036357. doi: 10.1161/JAHA.124.036357. Epub 2024 Nov 15.
PubMed 39548016Zoungas S, Curtis A, Spark S, Wolfe R, McNeil JJ, Beilin L, Chong TT, Cloud G, Hopper I, Kost A, Nelson M, Nicholls SJ, Reid CM, Ryan J, Tonkin A, Ward SA, Wierzbicki A; STAREE investigator group. Statins for extension of disability-free survival and primary prevention of cardiovascular events among older people: protocol for a randomised controlled trial in primary care (STAREE trial). BMJ Open. 2023 Apr 3;13(4):e069915. doi: 10.1136/bmjopen-2022-069915.
PubMed 37012015Rozing MP, Westendorp RGJ. Altered cardiovascular risk pattern of LDL cholesterol in older adults. Curr Opin Lipidol. 2023 Feb 1;34(1):22-26. doi: 10.1097/MOL.0000000000000859. Epub 2022 Nov 16.
PubMed 36413436
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of STAtins for Reducing Events in the Elderly (STAREE)
- ClinicalTrials.gov ID
- NCT02099123
- Acronym / sponsor ID
- STAREE / NHMRC 1068146
- Conditions
- Independent Living, Disability Free Survival, Elderly, Healthy
- Keywords
- Survival, Functional Disability, Cardiovascular Disease, Diabetes, Dementia, Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,971 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, National Heart Foundation, Australia
- Study start
- Jul 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Mar 2014 (estimated)
- 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.
The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong disability free survival and reduce major cardiovascular events amongst healthy elderly people (≥70 years).
Detailed description
Statin therapy has been shown to reduce the risk of vascular events in younger individuals with manifest atherosclerotic disease or at high risk of vascular events. However, data derived from meta-analyses of existing trials suggests that the efficacy of statins may decline sharply amongst those over 70-75 years of age. Insufficient patients of this age group have been included in major trials to be certain of the benefit. Within this age group part of the benefit of statin therapy may be offset by adverse effects including myopathy, development of diabetes, cancer and cognitive impairment, all of which are more prevalent in the elderly in any event.
The use of statins in the over 70 age group raises fundamental questions about the purpose of preventive drug therapy in this age group. When a preventive agent is used in the context of competing mortality, polypharmacy and a higher incidence of adverse effects its use should be justified by an improvement in quality of life or some other composite measure that demonstrates that the benefit outweighs other factors.
STAREE will determine whether taking daily statin therapy (40 mg atorvastatin) will extend the length of a disability-free life, determined from survival outside permanent residential care, in healthy participants aged 70 years and above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily |
| Placebo | Placebo comparator | Drug: Placebo (for Atorvastatin)Placebo (2 x 20 mg placebo) taken orally once daily |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women aged ≥70 years living independently in the community
- Willing and able to provide informed consent and accept the study requirements (Note: competent physical ability to participate in the trial is assessed using the KATZ ADL questionnaire)
Key exclusion criteria (11 listed)
- A history of cardiovascular disease (defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, coronary artery angioplasty and/or stenting, coronary artery bypass grafting, carotid stenosis, abdominal aortic aneurysm or heart failure),
- A history of dementia or a 3MS score <78 on screening,
- A history of diabetes,
- Total cholesterol >7.5 mmol/L,
- Moderate or severe chronic kidney disease (persistent proteinuria (Urine albumin:creatinine ratio >30mg/mmol or Urine protein:creatinine ratios >45 mg/mmol)45 and/or eGFR <45ml/min/1.73m2),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor, , , Cadivast, Caduet, Lorstat, Torvastat, Trovas, Atorachol, CadatinAtorvastatin 20 mg tablet | Drug | Atorvastatin |
| Placebo (for Atorvastatin)Also: no other namesInactive pill manufactured to mimic Atorvastatin 20 mg tablet | Drug | Placebo |
Primary outcome
Disability free survival - death or development of dementia or development of persistent physical disability
Time frame: Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Defined as survival free of dementia or persistent physical disability (as derived from the endpoints of all-cause mortality, dementia and physical disability)
Major cardiovascular events
Time frame: Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Defined as the first occurrence of a cardiovascular death or a non-fatal myocardial infarction or stroke or coronary revascularisation
16 secondary outcomes
A composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Cardiovascular death
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Fatal and Non-fatal Mycocardial infarction
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Hospitalisations
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Fatal and Non-fatal Cancer
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Other cognitive impairment
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Quality of life measured by the Short Form Health Survey (SF-36)
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Cost-effectiveness of statin
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Fatal and Non-fatal Stroke
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Approved need for permanent residential care
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Dementia
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Persistent physical disability
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
All cause death
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Heart failure
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Atrial fibrillation
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Revascularisation procedure
Time frame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
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 21 Nov 2024.
- Derived from this study: PubMed 42670961Zoungas S, Wolfe R, Moran C, Nicholls SJ, Cloud GC, Reid CM, Tauonkin AM, Beilin L, Wierzbicki AS, Chong TT, Broder JC, Curtis AJ, Flanagan Z, Hopper I, Ryan J, Spark S, McNeil JJ, Nelson MR; STAREE Investigators. Atorvastatin, Cardiovascular Events, and Disability-free Survival in Older Adults. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2607314. Online ahead of print.
- Derived from this study: PubMed 39548016Zoungas S, Moran C, Curtis AJ, Spark S, Flanagan Z, Beilin L, Chong TT, Cloud GC, Hopper I, Kost A, McNeil JJ, Nicholls SJ, Reid CM, Ryan J, Tonkin AM, Ward S, Wierzbicki AS, Wolfe R, Zhou Z, Nelson MR; STAREE investigator group. Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability-Free Survival in Older People. J Am Heart Assoc. 2024 Nov 19;13(22):e036357. doi: 10.1161/JAHA.124.036357. Epub 2024 Nov 15.
- Derived from this study: PubMed 37012015Zoungas S, Curtis A, Spark S, Wolfe R, McNeil JJ, Beilin L, Chong TT, Cloud G, Hopper I, Kost A, Nelson M, Nicholls SJ, Reid CM, Ryan J, Tonkin A, Ward SA, Wierzbicki A; STAREE investigator group. Statins for extension of disability-free survival and primary prevention of cardiovascular events among older people: protocol for a randomised controlled trial in primary care (STAREE trial). BMJ Open. 2023 Apr 3;13(4):e069915. doi: 10.1136/bmjopen-2022-069915.
- Derived from this study: PubMed 36413436Rozing MP, Westendorp RGJ. Altered cardiovascular risk pattern of LDL cholesterol in older adults. Curr Opin Lipidol. 2023 Feb 1;34(1):22-26. doi: 10.1097/MOL.0000000000000859. Epub 2022 Nov 16.
- Individual participant dataSharing planned: No. On completion of the trial, and after publication of the primary and secondary outcomes of the study, requests for access to de-identified data (to be provided through a secure online environment) may be submitted to the researchers located at the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
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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.
Sophia Zoungas, MBBS, FRACP principal investigator
Monash University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Independent Living and Disability Free Survival, run by Monash University at 6 sites in Australia.
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 2 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Disability free survival - death or development of dementia or development of persistent physical disability (time frame: Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.). The study lists 2 primary outcomes in all. 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 NCT02099123, which also lists 4 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 21 Nov 2024.