Alzheimer DiseaseIONA LCSNCT05892952
IONA Longitudinal Cohort Study
An observational study of Alzheimer Disease and Dementia, run by Brain Health Scotland Life Sciences Ltd at 1 site in United Kingdom.
Trial summary
Understanding more about how diseases that cause dementia develop is critical as the number of people living with, or affected by, dementia in Scotland continues to grow. The IONA Longitudinal Cohort Study (LCS) has been set up to gather information about people's cognitive health (their memory and thinking… Read more about this study
- Who is it for?
- Ages 50 to 120 years
- Conditions the study is for
- Alzheimer Disease, Dementia
- How many people
- 10,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Dec 2023to 21 Dec 2033
- How long will I take part?
- 10 Years
- 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 50 to 120 years
- All sexes
- Adult, Older adult
Study population: The IONA LCS is designed to be inclusive and from within this diverse population smaller sub-populations will be derived. Given the main objective of the programme, the study is open to people over the age of 50 who range from having no symptoms of neurodegenerative disease to those living with a dementia syndrome at the mild stage of illness. All participants will have the capacity to consent to the study at the baseline. Participants who develop moderate-to-severe dementia, and those who lose capacity to provide informed consent during the study, will remain in the study to ensure disease models can capture the full trajectories of these diseases. Recruitment strategies will be designed using the above five sources to ensure all people representative of the Scottish population (ensuring there is representation from different ages, sex, ethnicity, education, socioeconomic status) who are suitable for the IONA LCS are invited to participate.
- Age at least 50 years.
- Living in Scotland.
- Able to read and write and with minimum 7 years of formal education.
- Have a study partner who is aged 18 years or older.
- Have capacity to provide informed consent at baseline.
- Able to speak English to a level where the cognitive assessments can be completed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joseph Milne contact
United Kingdom1 site, 1 recruiting
- Recruiting
Scottish Brain Sciences Arran Facility
Edinburgh, Lothian, EH12 9DQ
Craig Ritchie, Prof, 0131 353 0233, c.ritchie@brainsciences.scot
About this study
Understanding more about how diseases that cause dementia develop is critical as the number of people living with, or affected by, dementia in Scotland continues to grow. The IONA Longitudinal Cohort Study (LCS) has been set up to gather information about people's cognitive health (their memory and thinking abilities), their lifestyle and health risk factors for future dementia (such as hearing loss and obesity), genetics and disease biomarkers, over a number of years. The IONA LCS has three main objectives: Firstly to develop this cohort that is well characterised (also known as being "well-phenotyped") that represent the Scottish population (taking into consideration age, sex, ethnicity and education). The second objective is to use this data to build disease models to better understand trajectories of diseases, and identify any sub-populations who have different (i.e. better, worse) disease trajectories. Finally the third objective for IONA LCS is to offer people an optional consent to hear about future studies they may be interested in taking part in.
Read the detailed description
IThe IONA Longitudinal Cohort Study (LCS) will provide a well-phenotyped (combining data on risk factors for dementia, cognitive assessment results, disease biomarkers and genetics) population representative of the Scottish population aged 50 and above across the spectrum of risk for, and the earliest disease stages of, AD dementia and other neurodegenerative conditions. Recent therapeutic successes in the treatment of Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD, as well as progressions in diagnostic tools such as blood-based biomarkers, has energised the field to develop more specific diagnostics and therapies following the best principles of precision medicine. Large, 'real world' cohorts are needed to understand whether these, and other future breakthroughs, are valid in real world populations away from highly selective clinical trials. Precision medicine requires identification of disease sub-populations who share similar diagnostic profiles that reflect similar disease mechanisms and hence are likely to respond consistently to specific therapeutic interventions. This will require detailed clinical, genetic and biological phenotyping. IONA LCS will recruit uniquely in Scotland and will ensure that a large, diverse, real-world population will be available to drive developments globally of more accurate diagnostics and accelerate the development of new disease modifying therapies.
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- cohort study, Alzheimer Disease, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time on the IONACog (a composite neuropsychological battery)
Measured: 10 years
(Enhanced Phenotype only) Change over time in cerebrospinal fluid amyloid beta-42
Measured: 10 years
(Enhanced Phenotype only) Change over time in cerebrospinal fluid phosphorylated tau 181
Measured: 10 years
(Enhanced Phenotype only) Change over time in cerebrospinal fluid total tau
Measured: 10 years
Secondary outcomes (4)
Change over time in dependency (as measured by the Stern Dependency Scale)
Measured: 10 years
Change over time in caregiver burden (as measured by the Zarit Burden Index)
Measured: 10 years
Change over time in quality of life (as measured by the QoL-AD)
Measured: 10 years
(Enhanced Phenotype only) impact of disclosure of Alzheimer's disease biomarkers as measured by the Impact of Events scale-6.
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 posted7 Jun 2023
- Study start21 Dec 2023
- Primary completion21 Dec 2033 (estimated)
- Study completion21 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Brain Health Scotland Life Sciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892952
- Sponsor's protocol ID
- BrainHealthScotland
- Acronym
- IONA LCS
- Status last verified
- Sep 2025
- First submitted
- 29 May 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IONA Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05892952
- Acronym / sponsor ID
- IONA LCS / BrainHealthScotland
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- cohort study, Alzheimer Disease, Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Brain Health Scotland Life Sciences LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 21 Dec 2033 (estimated)
- Study completion
- 21 Dec 2033 (estimated)
- First posted
- 7 Jun 2023 (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.
Understanding more about how diseases that cause dementia develop is critical as the number of people living with, or affected by, dementia in Scotland continues to grow. The IONA Longitudinal Cohort Study (LCS) has been set up to gather information about people's cognitive health (their memory and thinking abilities), their lifestyle and health risk factors for future dementia (such as hearing loss and obesity), genetics and disease biomarkers, over a number of years. The IONA LCS has three main objectives: Firstly to develop this cohort that is well characterised (also known as being "well-phenotyped") that represent the Scottish population (taking into consideration age, sex, ethnicity and education). The second objective is to use this data to build disease models to better understand trajectories of diseases, and identify any sub-populations who have different (i.e. better, worse) disease trajectories. Finally the third objective for IONA LCS is to offer people an optional consent to hear about future studies they may be interested in taking part in.
Detailed description
IThe IONA Longitudinal Cohort Study (LCS) will provide a well-phenotyped (combining data on risk factors for dementia, cognitive assessment results, disease biomarkers and genetics) population representative of the Scottish population aged 50 and above across the spectrum of risk for, and the earliest disease stages of, AD dementia and other neurodegenerative conditions. Recent therapeutic successes in the treatment of Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD, as well as progressions in diagnostic tools such as blood-based biomarkers, has energised the field to develop more specific diagnostics and therapies following the best principles of precision medicine. Large, 'real world' cohorts are needed to understand whether these, and other future breakthroughs, are valid in real world populations away from highly selective clinical trials. Precision medicine requires identification of disease sub-populations who share similar diagnostic profiles that reflect similar disease mechanisms and hence are likely to respond consistently to specific therapeutic interventions. This will require detailed clinical, genetic and biological phenotyping. IONA LCS will recruit uniquely in Scotland and will ensure that a large, diverse, real-world population will be available to drive developments globally of more accurate diagnostics and accelerate the development of new disease modifying therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The IONA LCS is designed to be inclusive and from within this diverse population smaller sub-populations will be derived. Given the main objective of the programme, the study is open to people over the age of 50 who range from having no symptoms of neurodegenerative disease to those living with a dementia syndrome at the mild stage of illness. All participants will have the capacity to consent to the study at the baseline. Participants who develop moderate-to-severe dementia, and those who lose capacity to provide informed consent during the study, will remain in the study to ensure disease models can capture the full trajectories of these diseases. Recruitment strategies will be designed using the above five sources to ensure all people representative of the Scottish population (ensuring there is representation from different ages, sex, ethnicity, education, socioeconomic status) who are suitable for the IONA LCS are invited to participate.
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
Change over time on the IONACog (a composite neuropsychological battery)
Time frame: 10 years
(Enhanced Phenotype only) Change over time in cerebrospinal fluid amyloid beta-42
Time frame: 10 years
(Enhanced Phenotype only) Change over time in cerebrospinal fluid phosphorylated tau 181
Time frame: 10 years
(Enhanced Phenotype only) Change over time in cerebrospinal fluid total tau
Time frame: 10 years
4 secondary outcomes
Change over time in dependency (as measured by the Stern Dependency Scale)
Time frame: 10 years
Change over time in caregiver burden (as measured by the Zarit Burden Index)
Time frame: 10 years
Change over time in quality of life (as measured by the QoL-AD)
Time frame: 10 years
(Enhanced Phenotype only) impact of disclosure of Alzheimer's disease biomarkers as measured by the Impact of Events scale-6.
Time frame: 10 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 19 Sep 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.
Joseph Milne contact
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 Alzheimer Disease and Dementia, run by Brain Health Scotland Life Sciences Ltd 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?
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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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?
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?
Contact Sarah Gregory, PhD (0131 353 0233, s.gregory@brainsciences.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over time on the IONACog (a composite neuropsychological battery) (time frame: 10 years). The study lists 4 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 19 Sep 2025.