IONA Longitudinal Cohort Study

NCT05892952 | Recruiting

• 1 other identifier: BrainHealthScotland
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Alzheimer Disease; Dementia

Keywords

cohort study; Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (4)

• Change over time on the IONACog (a composite neuropsychological battery)

  10 years

• (Enhanced Phenotype only) Change over time in cerebrospinal fluid amyloid beta-42

  10 years

• (Enhanced Phenotype only) Change over time in cerebrospinal fluid phosphorylated tau 181

  10 years

• (Enhanced Phenotype only) Change over time in cerebrospinal fluid total tau

  10 years

Secondary Outcomes (4)

• Change over time in dependency (as measured by the Stern Dependency Scale)

  10 years

• Change over time in caregiver burden (as measured by the Zarit Burden Index)

  10 years

• Change over time in quality of life (as measured by the QoL-AD)

  10 years

• (Enhanced Phenotype only) impact of disclosure of Alzheimer's disease biomarkers as measured by the Impact of Events scale-6.

  10 years

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brain Health Scotland Life Sciences Ltd: lead

Study Sites (1)

Scottish Brain Sciences Arran Facility

Edinburgh, Lothian, EH12 9DQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, Cerobrospinal Fluid samples

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Sarah Gregory, PhD

CONTACT

0131 353 0233; s.gregory@brainsciences.scot

Joseph Milne

CONTACT

j.milne@brainsciences.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 7, 2023
• Study Start: December 21, 2023
• Primary Completion (Estimated): December 21, 2033
• Study Completion (Estimated): December 21, 2033
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

GB (1)