Dementia AlzheimersNCT03943641
Dementia Risk Prediction Model: Development and Validation
An observational study of Dementia Alzheimers, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
At present, there is no treatment for dementia that changes the course of the disease. However, it is now understood that the proteins in dementias such as Alzheimer's disease are present years before someone develops symptoms of dementia. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- This is not an intervention study
- How many people
- 400,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2019to 5 Dec 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 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will use data from the Secure Anonymised Information Linkage Databank Dementia electronic Cohort (SAIL-DeC). SAIL-DeC was created as a flexible, national electronic cohort ('e-cohort') to facilitate dementia research using routinely-collected healthcare data. SAIL participants were included in SAIL-DeC based on date of birth (1/1/1900 to 1/4/1958) and if linked primary care data were available (1.2 million individuals).
Who may be able to join
- Registered with a SAIL practice before 2008
- Aged between 60-79 during the study window (1st January 2008 to 31st December 2017)
- Aged 60-79 years by January 2008
Who cannot join
- Deprivation quintile missing for the start of follow-up (deprivation scores will probably not be missing at random)
- All-cause dementia code in any dataset prior to 1st January 2008 (i.e. dementia diagnosis at baseline)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Usher Institute, University of Edinburgh
Edinburgh, Midlothian
About this study
Official title: Development and Validation of a Multivariable Dementia Risk Prediction Model in UK Adults Using Routinely Available Predictors
At present, there is no treatment for dementia that changes the course of the disease. However, it is now understood that the proteins in dementias such as Alzheimer's disease are present years before someone develops symptoms of dementia. Studies may therefore need to give potential treatments to patients before they develop symptoms of dementia. To do this, researchers need a way of predicting who will go on to develop dementia in the future.
There are several ways of doing this, however, many of these methods are costly and difficult to implement at a population level - such as brain imaging, lumbar punctures or psychological tests. In this study, the investigators aim to develop a method of predicting who will go on to develop dementia (and dementia due to Alzheimer's disease) using only the sort of information that a general practitioner would have available to them.
To do this, the investigators will develop a dementia prediction model using data from the Secure Anonymised Information Linkage (SAIL) Databank, which contains anonymised primary care, hospital admissions and mortality data for the population of Wales, United Kingdom (UK). They will then go on to test how well it performs in an external dataset, such as the UK's Clinical Practice Research Datalink (CPRD).
Read the detailed description
To date, no dementia drugs have shown a disease-modifying effect in clinical trials. It is now understood that the pathology underlying Alzheimer's disease is present decades before symptoms become apparent. Starting an intervention only when a patient develops cognitive symptoms, and therefore when there is substantial disease burden, may reduce the chance of any disease-modifying effect. Instead, targeting interventions earlier, when the pathological burden is lower, may increase the likelihood of preventing or delaying dementia onset.
Consequently, there is a need for a method that identifies patients who are at an increased risk of developing dementia. This requires the development of a risk prediction model, which utilises multiple predictors in combination to produce individualised estimates of the risk of developing dementia risk over time.
An ideal risk prediction model for a population-based application would need to use predictors that are already available to, or readily obtainable by, general practitioners (GPs). Such a predictive tool could be used as a low cost, scalable method of recruiting an 'at risk' group of participants to future trials of risk modification strategies or preventative therapies. Once an effective disease-modifying intervention is identified, clinicians could use the same model to identify at-risk patients who may benefit most from undergoing the intervention.
An ideal dementia risk prediction tool would contain only information that is readily available to, or easily obtainable by, clinicians such as General Practitioners (GPs).
The investigators aim to develop two 10-year risk prediction models: one to predict all-cause dementia and one to predict Alzheimer's disease dementia, in UK adults aged 60-79 years, using only predictors that are routinely available to GPs. They will develop the model using data from the Secure Anonymised Information Linkage (SAIL) Databank, which is composed of anonymised, linked primary care, hospital admissions and mortality data for the population of Wales, UK.
The investigators will then go on to externally validate their dementia risk prediction models in an external dataset, such as the UK's Clinical Practice Research Datalink (CPRD). They will also validate an existing, published study using data from the The Health Improvement Network (THIN) (Walters et al. 2016) using this external dataset, allowing us to compare the performance of the models.
- Conditions
- Dementia Alzheimers
- Being tested
- This is not an intervention study
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an intervention studyOther
This study is based on retrospective analysis of linked routinely-collected healthcare data
| Study group | Role | What they receive |
|---|---|---|
| Population-based | Population-based cohort of participants registered with a SAIL-contributing practice. Receives: Other: This is not an intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia
Development of dementia during follow-up
Measured: 10 years
Alzheimer's disease
Development of Alzheimer's disease dementia during follow-up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start8 May 2019
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia AlzheimersStudies 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
- Retrospective
- Enrolment
- 400,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Keele University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943641
- Sponsor's protocol ID
- AC19049
- Status last verified
- Dec 2024
- First submitted
- 7 May 2019
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers can apply to the SAIL databank (saildatabank.com) to access the individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multivariable Dementia Risk Prediction Model in UK Adults Using Routinely Available Predictors
- ClinicalTrials.gov ID
- NCT03943641
- Acronym / sponsor ID
- AC19049
- Conditions
- Dementia Alzheimers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,000 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Keele University
- Study start
- 8 May 2019 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 9 May 2019 (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.
At present, there is no treatment for dementia that changes the course of the disease. However, it is now understood that the proteins in dementias such as Alzheimer's disease are present years before someone develops symptoms of dementia. Studies may therefore need to give potential treatments to patients before they develop symptoms of dementia. To do this, researchers need a way of predicting who will go on to develop dementia in the future.
There are several ways of doing this, however, many of these methods are costly and difficult to implement at a population level - such as brain imaging, lumbar punctures or psychological tests. In this study, the investigators aim to develop a method of predicting who will go on to develop dementia (and dementia due to Alzheimer's disease) using only the sort of information that a general practitioner would have available to them.
To do this, the investigators will develop a dementia prediction model using data from the Secure Anonymised Information Linkage (SAIL) Databank, which contains anonymised primary care, hospital admissions and mortality data for the population of Wales, United Kingdom (UK). They will then go on to test how well it performs in an external dataset, such as the UK's Clinical Practice Research Datalink (CPRD).
Detailed description
To date, no dementia drugs have shown a disease-modifying effect in clinical trials. It is now understood that the pathology underlying Alzheimer's disease is present decades before symptoms become apparent. Starting an intervention only when a patient develops cognitive symptoms, and therefore when there is substantial disease burden, may reduce the chance of any disease-modifying effect. Instead, targeting interventions earlier, when the pathological burden is lower, may increase the likelihood of preventing or delaying dementia onset.
Consequently, there is a need for a method that identifies patients who are at an increased risk of developing dementia. This requires the development of a risk prediction model, which utilises multiple predictors in combination to produce individualised estimates of the risk of developing dementia risk over time.
An ideal risk prediction model for a population-based application would need to use predictors that are already available to, or readily obtainable by, general practitioners (GPs). Such a predictive tool could be used as a low cost, scalable method of recruiting an 'at risk' group of participants to future trials of risk modification strategies or preventative therapies. Once an effective disease-modifying intervention is identified, clinicians could use the same model to identify at-risk patients who may benefit most from undergoing the intervention.
An ideal dementia risk prediction tool would contain only information that is readily available to, or easily obtainable by, clinicians such as General Practitioners (GPs).
The investigators aim to develop two 10-year risk prediction models: one to predict all-cause dementia and one to predict Alzheimer's disease dementia, in UK adults aged 60-79 years, using only predictors that are routinely available to GPs. They will develop the model using data from the Secure Anonymised Information Linkage (SAIL) Databank, which is composed of anonymised, linked primary care, hospital admissions and mortality data for the population of Wales, UK.
The investigators will then go on to externally validate their dementia risk prediction models in an external dataset, such as the UK's Clinical Practice Research Datalink (CPRD). They will also validate an existing, published study using data from the The Health Improvement Network (THIN) (Walters et al. 2016) using this external dataset, allowing us to compare the performance of the models.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population-based | – | Other: This is not an intervention studyPopulation-based cohort of participants registered with a SAIL-contributing practice. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will use data from the Secure Anonymised Information Linkage Databank Dementia electronic Cohort (SAIL-DeC). SAIL-DeC was created as a flexible, national electronic cohort ('e-cohort') to facilitate dementia research using routinely-collected healthcare data. SAIL participants were included in SAIL-DeC based on date of birth (1/1/1900 to 1/4/1958) and if linked primary care data were available (1.2 million individuals).
Key inclusion criteria (3 listed)
- Registered with a SAIL practice before 2008
- Aged between 60-79 during the study window (1st January 2008 to 31st December 2017)
- Aged 60-79 years by January 2008
Key exclusion criteria (2 listed)
- Deprivation quintile missing for the start of follow-up (deprivation scores will probably not be missing at random)
- All-cause dementia code in any dataset prior to 1st January 2008 (i.e. dementia diagnosis at baseline)
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 |
|---|---|---|
| This is not an intervention studyThis study is based on retrospective analysis of linked routinely-collected healthcare data | Other | Population-based |
Primary outcome
Dementia
Time frame: 10 years
Development of dementia during follow-up
Alzheimer's disease
Time frame: 10 years
Development of Alzheimer's disease dementia during follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No. Researchers can apply to the SAIL databank (saildatabank.com) to access the individual participant data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia Alzheimers, run by University of Edinburgh at 1 site in United Kingdom.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dementia (time frame: 10 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?
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 10 Dec 2024.