Older adults at high dementia risk with Mental and Behavioural Disorders Mild Cognitive Impairment, Subjective Cognitive Decline
Conditions
Interventions
The study is interventional. It is an individually randomised single-blind multi-site randomised controlled trial. Participant's will be individually randomised using a web-based system (sealed envelo
Sponsors
UCL Joint Research Office
Eligibility
Sex/Gender
All
Age
60 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Age 60+ years 2. Cognitive Change Index score>16 indicating subjective cognitive impairment 3. Quick MCI score within educational and age normal range for MCI or SCD; CAIDE Dementia Risk Score =6 points (modifiable risk factors) 4. No dementia diagnosis 5. Functional Assessment Questionnaire score <9 (no significant impairment) 6. A relative, friend or professional in at least monthly contact who is able and willing to act as an informant
Exclusion criteria
Exclusion criteria: 1. AUDIT (Alcohol Use Disorders Identification Tool) score of 8+ (hazardous or harmful use of use of alcohol) 2. Primary neurodegenerative disease 3. Terminal condition which precludes carrying out the intervention 4. Lacking the capacity to consent to take part at baseline 5. We will exclude participants who have scheduled, regular sessions with one of the group facilitators 6. Unable to understand spoken English sufficiently to participate in the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition, using the modified Neuropsychological Test Battery (mNTB) composite z score at baseline, 12 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline, 12 months and 24 months: 1. Health and social care costs, measured using the Client Service Receipt Inventory (CSRI) 2. Quality of life, measured using the EQ-5D-5L 3. Functional Assessment Questionnaire, to measure activities of daily living 4. Neuropsychiatric Inventory to measure neuropsychiatric symptoms will be completed with an informant 5. Hospital Anxiety and Depression Scale 6. Measures of behaviour change: 6.1. Mediterranean Diet Score: to assess consumption of Mediterranean diet elements; e.g., olive oil, wine, fruits, legumes and whole-grain intake. Low consumption of meat, coffee, commercial sweets and fizzy drinks is reverse scored. Higher scores indicate greater dietary adherence 6.2. AUDIT (Alcohol Use Disorders Identification Tool) 6.3. Smoking status 6.4. Measures of primary support-network size, life events and the revised UCLA loneliness scale 7. Mobility limitations and physical functioning using the Short Physical Performance Battery (standing balance test, timed sit-to stand test, 4-m comfortable walking time); and blood pressure, weight and Body Mass Index (BMI), and hip and waist circumference 8. Physical activity over one week (after baseline assessment), using wearable sensors; and download cognitive training use from the website. 9. Blood indices: red blood cell fatty acid and vitamin C to evaluate dietary compliance. We will measure cardiovascular and cognitive biomarkers of risk including plasma total, LDL and HDL-cholesterol, triglycerides, glucose, HBA1c, BDNF (marker of neuronal function) and insulin. The Global Screening Array (Illumina) will be used to generate genome-wide genotype data for each participant and derive Alzheimer’s disease polygenic risk scores | — |
Countries
England, United Kingdom
Contacts
Public ContactMichaela Poppe
Outcome results
None listed