Mental and Behavioural Disorders
Conditions
Interventions
FINGER based multimodal lifestyle intervention
Self guided multimodal intervention
Sponsors
Aga Khan University kenya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 50 – 85 years. 2. CAIDE Dementia Risk Score =6 points (based on age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity; range 0–14 points). The CAIDE risk score will be calculated based on data already collected as part of the relevant register or newly collected as part of the screening for lifestyle process. 3. Cognitive performance at the mean level or slightly lower than expected for age according to local population norms. The aim of this screening for lifestyle is to exclude individuals with substantial cognitive impairment/dementia, but also high performers, with low likelihood of change over 24 months. The cognitive screening for lifestyle will be based on the IDEA test. 4. Proficiency in the local language i.e. fluency and literacy in English and/or major traditional dialect Swahili (Kiswahili), Igbo or Yoruba 5. Able to consent 6. Any medication affecting cognition must have a stable dose for =4 weeks.
Exclusion criteria
Exclusion criteria: 1. Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician). IDEA-IADL score =10), or high functioning level (IDEA > age-adjusted 70th centile 2. Current or past use of medications for AD or related diseases (e.g., cholinesterase inhibitors, memantine). 3. Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement. 4. Other known significant neurologic disease, including but not limited to Parkinson’s disease, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities. 5. Any other condition affecting safe engagement in the intervention, e.g. malignant disease, major depression, symptomatic cardiovascular disease, revascularization within the previous year. 6. Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation as judged by the study physician. 7. Coincident participation in the active phase of another intervention trial. 8. Severe health conditions/recent surgical or other major procedures preventing safe intervention engagement/ trial participation as judged by study physician (e.g., severe sensory impairment; on-going major psychiatric illness) Exclusion criteria affecting the engagement in the intervention will be evaluated by the study physician for those meeting the cognitive inclusion criteria. Internet literacy will be also evaluated to ensure that each participant is willing to engage with the remote components of the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropsychological performance measures using the modified Neuropsychological Test Battery composite z score. The Composite score will be an average of the three composite cognitive domain scores of the executive function, processing speed, and memory subtests. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite scores for A-NTB including memory, executive function, and processing speed domains (based on FINGER, “composite cognitive domain scores”). 2. Change in functioning outcomes measured using the Instrumental Activities of Daily Living (IDEA-ADL) questionnaire and healthy lifestyle changes measured using the Healthy Lifestyle Index, a composite score based on exercise, diet, lifestyle cardiovascular risk factors, social and cognitive activity, BMI, waist, waist/hip ratio, hip and head circumference, mid-upper arm circumference (MUAC), blood pressure, lipid profile and glucose metabolism. 3. Change in individual cardiovascular and metabolic risk factors as well as cardiovascular morbidity and mortality like incident cardiovascular disease (e.g., myocardial infarction, angina pectoris, transient ischemic attack, stroke, peripheral artery disease). 4. Change in diet measured using the FINGER healthy diet index, nutrients, and food intake. 5. Self-reported and objectively measured levels of physical activity, physical functioning, depression, anxiety, stress, sleep, resilience, flourishing, health-related quality of life, and utilization of healthcare resources We will also evaluate exploratory outcomes on potential effects of intervention on brain MRI (e.g., volumetry, cortical thickness, white matter lesions, cerebral blood flow, cerebrovascular reactivity), cerebral glucose metabolism on FDG-PET, amyloid and tau accumulation via CSF biomarkers, and AD-related blood markers (e.g. amyloid, tau, neurofilament light polypeptide). We will conduct a neuroimaging biomarker sub-study (following the African Dementia Imaging protocol) and Retinal imaging (following the protocol for the Deep and Frequent Phenotyping study). There will be subgroup analyses by e.g., age, sex, APOE e4 carrier status, baseline cognitive and functional level, and adherence to the intervention. We will monitor liver functioning using blood ALAT, ASAT, GGT. | — |
Countries
Kenya, Nigeria
Contacts
Public ContactChi Udeh;Adedoyin Momoh;Ogunyemi
Aga Khan University;University of Lagos
Outcome results
None listed