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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Anne Marie
Minihane
a.minihane@uea.ac.uk
Dr
Amy
Jennings
amy.jennings@uea.ac.uk
Organic, including symptomatic, mental disorders
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MedEx-UK is a RCT that will evaluate the feasibility of a multi-domain intervention to increase Mediterranean Dietary Pattern (MDP) adherence and physical activity (PA) in a group of older UK adults who are at above average risk of dementia.
In cohort studies, an MDP has been consistently associated with reduced dementia incidence. The efficacy of an MDP to prevent dementia has never been directly demonstrated by RCTs, with existing research limited to cognition as a secondary outcome in a single study. Furthermore, despite their likely additive effects, the combined impact of PA and a MDP on dementia risk is unknown.
In MedEx-UK we propose to conduct a feasibility study in three UK centres (Norwich, Birmingham, Newcastle) which collectively will recruit 108 UK older adults (55-74y) who are above average risk of dementia, but pre-clinical. Our primary outcome is to increase MDP adherence and PA over a 24 week period, to demonstrate that it is possible to achieve meaningful behavioral change in such a UK population. Our secondary outcomes will be to measure the sensitivity of various cognitive assessments and measure the variability of our primary and secondary outcome measures in this population at baseline and in response to intervention.
The overall purpose of this feasibility study is to inform the future design of a large-scale UK dementia risk reduction RCT, to observe whether a multi-domain intervention over 2 to 5 years promoting MDP adherence and increased PA can reduce cognitive decline and brain atrophy in adults at above average risk of dementia.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Dietary;Psychological & Behavioural;Physical;
You can take part if:
You may not be able to take part if:
HEALTH: • Diagnosis of Alzheimer’s disease (AD), other form of dementia, Mild Cognitive Impairment (MCI), or significant neurological disorder • Cognition not within normal range, based on a score of < 26 on the Montreal Cognitive Assessment (MoCA). Or, indication of cognitive decline, based on a score of > = 2 on Ascertian Dementia (AD-8) • Evidence of impairment of Instrumental Activities of Daily living (IADLS) • Moderate to severe depression, assessed by the Patient Health Questionnaire (PHQ-9), a score of > 10 being exclusionary • Moderate to severe anxiety, assessed by the Generalised Anxiety Disorder Assessment (GAD-7), a score of > 10 being exclusionary • Current psychotic illness (delusional disorder/schizophrenia) • History of serious mental illness know to affect cognition (schizophrenia, schizoaffective disorder, bipolar disorder) • Subjects with other clinically diagnosed psychiatric disorders likely to affect the cognitive measures (as judged by a clinical advisor) • HIV positive • Past history or previous MRI evidence of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery, stroke, or serious neurological disorders • History of alcohol or drug dependency in the last 2 years • Subjects with existing diagnosed gastrointestinal disorders likely to impact study results (as judged by a clinical advisor) • History of any major cardiovascular event, such as a myocardial infarction, stroke or TIA • Diagnosed COPD • Cancer, or cancer/treatment within the last 12 months • Diagnosis of type 1 or type 2 diabetes < 3 months ago • Clinical diagnosis of liver or kidney disease • Diagnosed Epilepsy • Subjects with any other existing medical conditions likely to affect the study measures • BMI > 40kg/m2 LIFESTYLE: • A habitual Mediterranean Diet Score (MDS) > = 9 • Habitual physical activity of > 60 minutes moderate activity per week, assessed using the International Physical Activity Questionnaire (IPAQ), short form • Currently actively engaged in a weight loss, other dietary, or physical activity intervention • Prescribed medications likely to influence the study measures (as judged by a clinical advisor) OTHER: • Currently a participant or have participated in any other study involving an investigational product in the last 4 weeks • Metal implants, e.g. pacemaker that precludes MRI. • Claustrophobic which precludes MRI scanning.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of East Anglia and funded by Alzheimer's Research UK .
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for Trial ID: CPMS 40181
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