Title of study

    ASPirin in reducing Events in the Elderly: an RCT of low dose aspirin

    Acronym for cohort

    ASPREE

    Name of Principal Investigator - Title

    Prof

    Name of Principal Investigator - First name

    John

    Name of Principal Investigator - Last name

    McNeil

    Address of institution -Institution

    Monash University

    Address of institution - Street address

    99 Commercial Road

    Address of institution - City

    Melbourne

    Address of institution - Postcode

    3004

    Country

    Australia

    Contact email
    Funding source

    NIH

    Q1a. Please indicate below if your cohort includes or expects to include, incidence of the following conditions?

    Alzheimer's disease and other dementias|Parkinson's disease

    Q2a. In a single sentence what is the stated aim of the study? (Maximum 30 words)

    To determine whether regular low dose aspirin extends survival free of dementia and persistent physical disability

    Q2b. What distinguishes this case-control study from other studies?

    This is not a case control study but an RCT over an average of 5 years of treatment

    Q3a. i) Number of publications that involve use of your cohort to date

    5

    Q3a. ii) Please give up to three examples of studies to date (PI, Institution, Title of Study)

    John McNeil, Monash University, Methods and rationale paper for ASPREE|John McNeil, Monash University, Methods and rationale paper for ASPREE|Elsdon Storey, Monash University, Methods and rationale paper for sub-study on neurocognitive function and neuroimaging (ENVISION)

    Q3b. If data on research outputs are already available please paste the publication list/other data or provide a link to where these data are publicly available

    Q3c. If no research has been done as yet, please explain in a few sentences what information (i.e. research findings) you expect will be gained from the case-control study

    The RCT will determine the primary prevention benefits of low dose aspirin in elderly people

    Q4a. Study criteria: what is the age range of participants at recruitment? Age in years From:

    70

    Q4a. Study criteria: what is the age range of participants at recruitment? To:

    until death

    Q4b. Study criteria: what are the inclusion criteria?

    Able to give informed consent and attend a general practice; aged 70+; either gender; generally 'healthy'

    Q4c. Study criteria: what are the exclusion criteria?

    History of CVD, dementia, loss of independence, anaemia, very high blood pressure, bleeding risk

    Q5a. What is the size of the cohort (i.e. how many participants have enrolled)?

    More than 15,000

    Q5b. What is the expected number of control participants?

    Above 5,000

    Q6a. Please describe what measures are used to characterise participants

    Neurocognitive assessments, physical and clinical criteria

    Q6b. Are there additional measures for participants with the clinical disorder?

    No clinical disorder

    Q6c. Are there defined primary and secondary endpoints (e.g. defined health parameters)?

    Yes

    If YES please specify

    death, dementia, persistent physical disability, CVD, stroke, cancer, depression, clinically significant bleeding

    Q7. What is the study design?

    Randomized Controlled Trial

    Q8. Are your cases matched by

    Q9a. Does your study includes a specialised subset of control participants?

    No

    Q9b. If your study includes a specialised subset of control participants please describe

    Q10a. Is data collection for this study

    Data collection ongoing

    Q10b. If data collection is ongoing, are there plans to continue the cohort study beyond the current projected end date?

    Yes - intend to apply for funding

    Q11. Are data collected

    Only through the study|Through links to medical records|Through links to other records or registers(Cancer and other registries)

    Q12. Is there a system in place to enable re-contact with patients for future studies?

    Yes (participants have given permission to be re-contacted via the PIs)

    Q13a. Please give information on data stored in a database (1)

    Data summarised in database

    % Available

    Q13a. Please give information on data stored in a database (2)

    Database is web-based

    % Available

    Q13a. Please give information on data stored in a database (3)

    No

    % Available

    Q13a. Please give information on data stored in a database (4)

    No

    % Available

    Q13a. Please give information on data stored in a database (5)

    No

    % Available

    Please specify language used

    % Available

    Q13b. Please give information on how data is held as individual records

    No

    % Available

    Q14a. Are data available to other groups?

    No

    Q14b. If data is available to other groups what is the access policy/mechanisms for access?

    Q15. What data sharing policy is specified as a condition of use?

    Data made publicly available after a specified time point

    Q16a. Are tissues/samples/DNA available to other groups?

    No

    Q16b i) If yes, please describe below

    Q16b. ii) In what form are tissues/samples/DNA supplied?

    Q16b iii) Is the access policy/mechanism for obtaining samples the same as that for obtaining data (Q14 above)?

    No

    Q17. Is information on biological characteristics available to other groups?

    No

Types: Case Control Studies
Member States: Australia
Diseases: Alzheimer's disease & other dementias, Parkinson's disease & PD-related disorders
Years: 2016
Database Categories: N/A
Database Tags: N/A

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