scholarly journals Walking or vitamin B for cognition in older adults with mild cognitive impairment? A randomised controlled trial

2008 ◽  
Vol 42 (5) ◽  
pp. 344-351 ◽  
Author(s):  
J G Z van Uffelen ◽  
M J M Chinapaw ◽  
W van Mechelen ◽  
M Hopman-Rock
Keyword(s):  
Older Adults ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Vitamin B ◽  
Randomised Controlled

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041891
Author(s):  
André Kratzer ◽  
Jennifer Scheel ◽  
Karin Wolf-Ostermann ◽  
Annika Schmidt ◽  
Katrin Ratz ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mixed Methods ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
People With Dementia ◽  
Randomised Controlled

IntroductionShared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation. Thus, the DemWG study investigates whether a complex intervention is effective in reducing hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life in people with dementia and mild cognitive impairment (MCI) in German SHAs.Methods and analysisBased on the UK Medical Research Council framework ‘Developing and evaluating complex interventions’, a prospective, mixed-methods, multicentre, cluster-randomised controlled trial combining primary and secondary data analyses as well as quantitative and qualitative research methods is being conducted. The intervention consists of three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ (‘m’=motor training; ‘k’=cognitive training; ‘+’=fall prevention) for people with dementia and MCI. Randomisation is stratified by the German federal states and type of setting (rural vs urban). Neither the trained professionals nor the participants are blinded. Data are collected at baseline and after 6, 12 and 18 months with standardised instruments. Quantitative data will be analysed by multivariate analyses according to the general linear model, qualitative data using qualitative content analysis. Recruitment is still ongoing until 31 December 2020.Ethics and disseminationAll procedures were approved by the Ethics Committee of the University of Bremen (Ref. 2019-18-06-3). Informed consent will be obtained before enrolment of participants. Due to findings of previous randomised controlled trials, serious adverse events are not expected. Results will be disseminated in peer-reviewed journal publications and conference presentations.Trial registration numberISRCTN89825211.

Computerised Cognitive Training for Older Persons With Mild Cognitive Impairment: A Pilot Study Using a Randomised Controlled Trial Design

2011 ◽  
Vol 12 (3) ◽  
pp. 187-199 ◽  
Author(s):  
Maurice Finn ◽  
Skye McDonald
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Cognitive Training ◽  
Visual Memory ◽  
Controlled Trial ◽  
Future Research ◽  
Neuropsychological Measures ◽  
Memory Functioning ◽  
Randomised Controlled

AbstractThe results of a pilot randomised controlled trial of computerised cognitive training in older adults with mild cognitive impairment (MCI) are reported. Participants (N = 25) were randomised into either the treatment or waitlist training groups. Sixteen participants completed the 30-session computerised cognitive training program using exercises that target a range of cognitive functions including attention, processing speed, visual memory and executive functions. It was hypothesised that participants would improve with practice on the trained tasks, that the benefits of training would generalise to nontrained neuropsychological measures, and that training would result in improved perceptions of memory and memory functioning when compared with waitlist controls. Results indicated that participants were able to improve their performance across a range of tasks with training. There was some evidence of generalisation of training to a measure of visual sustained attention. There were no significant effects of training on self-reported everyday memory functioning or mood. The results are discussed along with suggestions for future research.

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