NCT03943641

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

5.6 years

First QC Date

May 7, 2019

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dementia

    Development of dementia during follow-up

    10 years

  • Alzheimer's disease

    Development of Alzheimer's disease dementia during follow-up

    10 years

Study Arms (1)

Population-based

Population-based cohort of participants registered with a SAIL-contributing practice.

Other: This is not an intervention study

Interventions

This study is based on retrospective analysis of linked routinely-collected healthcare data

Population-based

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usher Institute, University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

May 8, 2019

Primary Completion

December 5, 2024

Study Completion

December 5, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Researchers can apply to the SAIL databank (saildatabank.com) to access the individual participant data.

Locations