Age-associated cognitive decline, subjective memory concerns and/or family history of dementia Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 07/07/2023:
Participants will be randomised into either the treatment or control arm of the study.
Randomisation is achieved through simple randomisation delivered through
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/04/2020: 1. Age 50 years and over 2. Already registered as a participant in the PROTECT study 3. Fulfilling research criteria for dementia risk: Either (1) Performing at least one Standard Deviation below age-matched population norms in two cognitive tests as measured using the validated PROTECT and online cognitive test battery; and/or (2) Reporting subjective memory concerns; and/or (3) Reported family history of dementia 4. Fulfilling criteria for vitamin D deficiency risk: Defined by a self-reported scale to be completed on registration. 5. Access to a computer and the internet. _____ Previous inclusion criteria: 1. Aged 50 years and over 2. Already registered as a participant on the PROTECT study 3. Fulfilling the AACD criteria: performing at least standard deviation below age-matched population norms in two cognitive tests, as measured using the validated PROTECT and CogTrackTM online cognitive test batteries 4. Fulfilling criteria for vitamin D deficiency risk (defined by a self-reported scale to be completed upon registration (based on Annweiler et al., 2017) 5. Access to a computer and the internet
Exclusion criteria
Exclusion criteria: 1. Diagnosed with dementia 2. Already participating in another active interventional clinical trial 3. Regularly taking any supplement containing vitamin D: 3.1. If the supplement is prescribed for a pre-existing condition, the participant will be excluded 3.2. If the supplement is bought over the counter, the participant will have the option of stopping the supplement and re-registering for the trial after a 28 day washout period 4. Prescribed the medication Digoxin (Lanoxin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 03/07/2023: Executive Function (Trails B) measured through online assessment using the PROTECT online test battery at baseline, 26, 52, and 104 weeks. This measure has been used to assess cognitive change in adults with dementia risk extensively in the literature (e.g. Park 2022, Kim et al 2021). Previous primary outcome measure as of 23/07/2019: Executive Function (Baddeley Grammatical Reasoning) measured through online assessment using the PROTECT online test battery at baseline, 26, 52, 104 and 156 weeks. This measure has been used to assess cognitive change in adults with AACD in a recent large online clinical trial (Corbett, et al. 2015a). Previous primary outcome measure: Executive Function (Baddeley Grammatical Reasoning) measured through online assessment using the validated cognitive assessment battery, CogTrack™, at baseline, 26, 52, 104 and 208 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/07/2023: The following outcomes were measured at the baseline, 26, 52, and 104 weeks: 1. PROTECT Cognitive Test Battery (Paired Associate Learning, Digit Span, Self-Ordered Search Task [working / spatial memory tasks], Switching Stroop and Grammatical Reasoning [Executive Function Tasks]) 2. Instrumental Activities of Daily Living 3. EQ5D measure of health and wellbeing 4. Mild Behaviour Impairment Scale 5. Anonymous online survey to capture participant experience of the study Previous secondary outcome measures as of 23/07/2019: The following outcomes were measured at the baseline, 26, 52, 104 and 156 weeks: 1. Full PROTECT Cognitive Test Battery (Reaction time, Attentional Indices, Paired Associate Learning, Digit Span and Self-Ordered Search Task, Digit Vigilance, Verbal Learning, Spatial Working Memory, Executive Function) 2. Instrumental Activities of Daily Living 3. EQ5D measure of health and wellbeing 4. Mild Behaviour Impairment Scale Previous secondary outcome measures: The following outcomes were measured at the baseline, 26, 52, 104 and 208 weeks: 1. Full PROTECT Cognitive Test Battery (PROTECT test battery (Digit Vigilance, Verbal Learning, Spatial Working Memory, Executive Function) 2. Full CogTrack™ test Battery (Reaction time, Attentional Indices, Paired Associate Learning, Digit Span and Self-Ordered Search Task) 3. Instrumental Activities of Daily Living 4. EQ5D measure of health and wellbeing 5. Mild Behaviour Impairment Scale | — |
Countries
England, United Kingdom
Outcome results
None listed