Alzheimer's disease, dementia Nervous System Diseases
Conditions
Interventions
Objective:
The primary objective is to test the accuracy of individual and combinations of novel biomarkers, collected remotely and in primary care clinics to diagnose AD.
Research questions:
Primar
Sponsors
Stavanger University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1: 1. Adults aged 50 years or above 2. Access to a computer (or touchscreen device) and the internet 3. Participant is willing and able to give informed consent for participation in the study 4. In the UK and Norway, already an active participant in the PROTECT-UK or PROTECT-Norge cohort respectively 5. Willing and able to visit one of the PREDICTOM research centres 6. Symptoms or risk profile indicating an increased risk of AD or related disorders, operationalized as having at least one of the below: 6.1. Subjective cognitive complaints 6.2. AD or dementia in a first-degree relative 6.3. At least one cardiometabolic disorder known to be a risk factor for dementia (e.g. diabetes, obesity, hypertension, hypercholesterolemia, cerebrovascular disease or coronary disease or peripheral arterial disease) Cohort 2: Criteria for high and low risk will be defined based on a machine learning algorithm based on retrospective data from existing datasets and refined with data from the Cohort 1 assessments and sampling. Thresholds will be set for high and low risk within a centralised dataset. The exact algorithm will be developed and completed prior to the first participant completing Level 1 testing. Criteria will include: 1. Relative risk scores for each of the 12 modifiable risk factors from the Lancet Commission (1) 2. Family history of dementia. 3. APOE genotype 4. Cognitive test performance from Cohort 1 testing 5. Blood biomarkers from finger prick blood test performed in Cohort 1 6. Data from other relevant Level 1 tests. 7. Willing and able to give informed consent for the Cohort 2 protocol
Exclusion criteria
Exclusion criteria: 1. An established diagnosis of dementia 2. Life-threatening physical disease 3. Active major psychiatric disorder which is inconsistent with being able to complete informed consent or perform the procedures 4. Unable to speak native tongue 5. Neurodevelopmental disorder, sensory or other physical impairment or other factor making the person unable to complete the study procedures 6. Major disabling stroke, e.g., clinically significant symptoms and/or functional impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Memory function measured through FLAME Cognitive test online at home baseline and within 12 months 2. Lifestyle factors measured through Lifestyle & Medical Risk Factors Questionnaire at home baseline 3. Family history of dementia measured through Family History of Dementia Scale Questionnaire at home baseline 4. Self-reported memory function changes measured through Subjective Cognitive Decline Questionnaire at home baseline 5. Mood measured through Patient Health Questionnaire at home baseline 6. Mood measured through General Anxiety Disorder (Anxiety) Questionnaire at home baseline 7. Loneliness measured through U-CLA 3 (Loneliness) Questionnaire at home baseline 8. Activities of daily living measured through ADL Amsterdam Participant and Informant (optional) Questionnaire at home baseline 9. Hearing measured through Hearing Screening Hearing test online at home baseline and follow up within 12 months 10. Memory function measured through eye tracking online task at home baseline 11. Memory function measured through Banking app task Cognitive test online at home baseline 12. Memory function measured through Altoida (augmented reality task) Cognitive test online at home baseline 13. Memory function measured through BrainCheck Assess Cognitive test online at home baseline 14. Feasibility of the PREDICTOM platform measured through questionnaire at home baseline 15. Biomarkers for dementia measured through saliva sample (genetics/epigenetics) sample kit at home baseline 16. Biomarkers for dementia measured through fingerprick blood test (biomarkers) sample kit at home baseline and follow up within 12 months 17. Biomarkers for dementia measured through stool sample (microbiome) sample kit at home baseline 18. General wellbeing and function measured through physical examination in Clinic/hospital within 12 months 19. Memory function measured through Montreal Cognitive Assessment in Clinic within 12 months 20. Biomarkers for dementia measured through venous blood | — |
Secondary
| Measure | Time frame |
|---|---|
| Health cost and service use measured by Resource in Dementia scale at baseline and within 12 months | — |
Countries
Belgium, England, France, Germany, Norway, Spain, Switzerland, United Kingdom
Contacts
Public ContactDag;Zunera Aarsland;Khan
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Outcome results
None listed