IONA LCS: IONA Longitudinal Cohort Study
Study Details
Study Description
Brief Summary
IONA LCS is a research project that will allow the testing of multiple new therapies as well as diagnostic tests for neurodegenerative diseases. IONA LCS acts primarily as a readiness cohort for interventional studies targeting the treatment of neurodegenerative disease but also provides data as the reference standard to validate new diagnostic tests. As such, it is a foundational element to support a range of research projects undertaken by Scottish Brain Sciences and our partners.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
IONA LCS has been established to overcome the major hurdles hampering development of novel therapeutics and diagnostics for the treatment and detection of neurodegenerative disease at early and therapeutically amenable stages of disease. There has been recent therapeutic success in treating Mild Cognitive Impairment (MCI) due to Alzheimer's dementia (AD) and mild AD and this has energised the field to develop more specific therapies following the best principles of precision medicine. To achieve this mid to long term goal very large cohorts of study participants who are deeply phenotyped and reflect the background 'real world' population in terms of ethnic, cultural, gender and socioeconomic diversity are needed. 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. The 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
Outcome Measures
Primary Outcome Measures
- To provide a well-phenotyped population (readiness population) for clinical trials targeting modification of neurodegenerative disease course. [5 years]
- To provide a research environment, dataset and accessible research population for the validation of a range of new diagnostic tests and detection mechanisms for early disease in a real world and therein generalisable population. [5 years]
- To provide a real-world control group for Phase IV and other real-world trials. [5 years]
- To provide data to aid in the development of prognostic models to feed into the creation of decision support tools for use in clinical services nationally. [5 years]
- To use disease models for assessing where and why study participants fall in the overall probability continuum spectrum, and thereafter select study participants for other clinical trials. [5 years]
- To provide real world data through assessment and data linkage to inform health economic and care pathway modelling. [5 years]
- To provide reports on secular disease surveillance and risk factor prevalence in Scotland. [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age at least 50 years.
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Telephone Interview of Cognitive Status score of >21.
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Able to read and write and with minimum 7 years of formal education.
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Have access to the internet either in their own home or a community facility.
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Willing in principle to participate in other clinical research.
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Have a study partner or can identify someone willing in principle to be a study partner.
Exclusion Criteria:
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Telephone Interview of Cognitive Status score of <22
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Diminished decision-making capacity/not capable of consenting.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scottish Brain Sciences Arran Facility | Edinburgh | Lothian | United Kingdom | EH12 9DQ |
Sponsors and Collaborators
- Brain Health Scotland Life Sciences Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BrainHealthScotland