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P7. Research with people with dementia

Detailed programme, abstracts and presentations

P7.1. Managing eligibility, amyloid related imaging abnormalities (ARIA), and efficacy evaluations in Alzheimer disease clinical trials: Points to consider

Shamsi Kohkan, Patt Rick

Alzheimer disease is extensively being investigated in clinical trials. Imaging is utilised for patient’s eligibility, efficacy evaluation and safety evaluations. Patient’s eligibility, efficacy and safety are evaluated by Magnetic Resonance Imaging (MRI) and FDG-PET is used for efficacy assessments.

Evaluation of images for patient eligibility:  Many neurological diseases that could either have similar presentation as Alzheimer disease or could be confounding factors in the assessment of drug therapy have to be excluded to evaluate therapeutic effect of a drug on AD patient population. These include vascular dementia, multiple sclerosis, vascular pathology, neoplasms etc. Inclusion of wrong patient has serious have ethical and legal issues. More importantly, these patients could be excluded from the analysis thereby reducing the sample size and impacting the power of the study and the study results. In this presentation, various strategies of eligibility evaluation will be presented and optimisation of eligibility read process will be discussed

Evaluation of Amyloid Related Imaging Abnormalities (ARIA): Initially these abnormalities were observed in monoclonal antibody against amyloid-β (Aβ) trials. These MRI findings include vasogenic edema (ARIA E). micro and macro hemorrhages (ARIA H) and superficial siderosis.  FDA has mandated that patients must frequently be followed by MRI in all AD trials and if ARIA is observed, the patient should be discontinued and should be followed by MRI more frequently till the finding is resolved or stabilised. This requirement has put additional burden on both sites and patients who have to undergo MRI every 3 months. These MRIs have to be evaluated in a standardised fashion with very quick turnaround time as patient status in the study is dependent on MRI findings. We will present our experience in conducting MRI evaluations for ARIA and suggest best practices to conduct ARIA evaluations

Efficacy evaluation: MRI is utilised to evaluate total brain volume or hippocampal volume. FDG PET has been used to measure metabolic activity of brain. Recently Amyloid imaging agents have been approved and are being utilised for drug evaluations. Site qualification including phantom imaging, image standardisation and image acquisition is crucial for the success of efficacy evaluations.

In this presentation, we will share our experience regarding issues related to site read, central independent reads, technology will be discussed and risk management strategies including protocol development, site selection process, core lab selection and training of the sites and reader management will be presented.

P7.2. Obtaining and maintaining consent for research participation from patients with impaired capacity: Best practice recommendations from the MORECare consultation workshop on ethical issues in palliative care research

Gysels Marjolein, Evans Catherine, Lewis Penney, Speck Peter, Benalia Hamid, Preston Nancy, Grande Gunn, Short Vicky, Owen-Jones Elly, Todd Chris, Higginson Irene J

Background: There is little guidance on the particular ethical concerns that research raises for people with dementia.

Aim: To present the recommendations on obtaining and maintaining consent for research participation from patients with impaired capacity, and their families, as achieved from a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care.

Design: Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated.

Setting/participants: Experts in ethical issuesand palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees, and policy makers.

Results: The workshop comprised 28 participants. Five key recommendations on informed consent were developed.  Also seven recommendations were developed on participation in research by a palliative care population and four on making applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Two recommendations were refined on the basis of the comments from the online consultation.

Conclusion: The culture surrounding research with patients with impaired capacity needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research with patients with impaired capacity. The recommendations are relevant to all areas of research involving vulnerable adults.

P7.3. Experience of people with dementia and their carers in a major clinical trial

McCrae Niall, Smythe Analisa, Wright Jan, Douglas Lisa, Leyland Helen, Davison Jill, Pearson June, Chadha Divya, Li Ryan, Poppe Michaela, Nurock Shirley, Murray Joanna, Banerjee Sube

Background: Fundamental to research is free, informed and competent participation, but a considerable challenge in generating evidence on treatment for people with dementia is the effect of cognitive impairment on capacity. Consent in clinical trials is covered by the Medicines for Human Use (Clinical Trials) Regulations (2006), which requires consent at the outset but not ongoing review of decision-making capacity. In many cases consent is provided by a carer acting as personal legal representative. However, such carers are often frail and may have limited understanding of the clinical trial process, despite information provided prior to consent.

Aim: This study explored the understanding and experiences of people with dementia and their carers in a major multi-centre clinical trial (HTA SADD). 

Method: Qualitative interviews were conducted with 14 people with dementia and 24 carers (including 14 dyads) at five trial sites.

Findings: Thematic analysis revealed that while participants were satisfied with their experience of the trial, limited understanding was apparent in relation to the purpose and process of the trial. Some carers, as well as most of the people with dementia, had seen the trial as part of normal clinical care, and had expected that an active treatment was being taken.

Conclusion: While there is a growing need for involvement of people with dementia and their carers in clinical research, more attention must be paid to informed consent. The authors recommend a person-centred approach to consent in dementia research.

P7.4. Considerations when involving people with dementia in research

Borley Gayle, Sixsmith Judith, Church Sarah

Dementia is one of the largest problems facing healthcare services in the future (DoH, 2010).  UK Prime Minister David Cameron has set a dementia challenge to promote the quality of life of people with the disease (DoH, 2012). Included in this challenge is the clear directive that more research needs to be undertaken in order to understand how this disease affects individuals.  A target has been set to recruit 10% of people living with dementia into high quality research by 2015.

Recruitment into research across all healthcare settings is known to be a challenge, particularly research into dementia (Abley, 2010).  There are multiple reasons why individuals may or may not take up the opportunity to be involved in research including level of commitment, study duration and agreement of family members (Marcantonio et al, 2008). Despite investigation of this issue over recent years, it remains a challenge.

This abstract will explore the challenges involved in recruiting individuals with mild to moderate dementia into research.  It will focus on and discuss issues related to women with Alzheimer’s disease currently being recruited as part of a doctoral study exploring the lived experience of becoming cared for.

It will incorporate the importance of recruitment strategies focusing on study design, inclusion/exclusion criteria, capacity to consent and most importantly the individuality of people with dementia and their families. It will also offer suggestions on how to involve people with dementia in the recruitment phase to assist with problems concerning finding potential participants and gatekeepers.

P7.5. Development of an easy-to-use videophone for people with dementia

Nygard Louise, Boman Inga-Lill, Lundberg Stefan, Rosenberg Lena

The aim was to develop a design concept and design an easy-to-use videophone with picture screen, i.e. a videophone, to be used by persons with dementia, and also to introduce this product to pilot cases. We have used an Inclusive Design approach that includes the target users in the design process.

First, the need of a videophone was examined and a requirement specification and a preliminary design concept was developed. Thereafter, data from five focus group interviews were analysed with a Grounded Theory approach. Group 1: Occupational therapists (n=8); Group 2-3: Significant others to people with dementia, SOs (n=5+5); Group 4-5: Persons with AD (n=2+4). The findings showed that there were more similarities than differences between the viewpoints of the different samples. The most evident difference was that significant others wanted to be able to monitor the person with dementia when they were away from home in order to check that everything was well. The persons with dementia, however, stated clearly that they did not want to be monitored, and they expressed a strong wish to be in control.

Our final step in this project was to let users with dementia and their significant others (SOs) test the usability of the video telephone design concept. We constructed a mock-up of the design concept, and invited users (4 persons with dementia and 4 SOs) to test it in the living lab at The Royal School of Technology in Stockholm. The participants were asked to carry out three different tasks; first, to make a videophone call to their SO in the room next-by, secondly, to answer a videophone call from their significant other, and thirdly, to make a call to SOS (although the mock-up was not connected to SOS). The participants with dementia perceived that it was useful, enjoyable and easy to use although they initially had difficulties to understand how to handle some functions, which indicates that the design needs to be further developed to be more intuitive.

Conclusions: The findings suggest that the videophone has potential to enable telephone calls without assistance and add quality in communication.

P7.6. Alzheimer Europe recommendations on the ethics of dementia research

Gove Dianne

In 2011, Alzheimer Europe set up a multidisciplinary working group to discuss the ethical issues linked to dementia research. A report was produced covering several issues such as informed consent, the involvement of people with dementia in the research process, protecting wellbeing, balancing risk, benefit and burden, avoiding paternalism, specific issues related to medical research, end-of-life care research and brain tissue donation, and issues surrounding the publication and dissemination of the results of dementia research.  The ethics working group produced detailed recommendations on each of these topics as well as three documents covering issues to consider when designing consent forms and participant information forms, and in relation to applications for the ethical approval of studies.

In this presentation, three topics will be addressed: 1. The full and fair involvement of people with dementia in dementia research (emphasising the need to ensure that older people with dementia and people with different types and stages of dementia and from different sub-groups of the population are involved); 2. The need to balance respect for autonomy and inclusion with protection from harm, and 3. The ethical and responsible publication and dissemination of findings. 

 

 
 

Last Updated: Monday 04 November 2013

 

 
  • Acknowledgements

    The 23rd Alzheimer Europe Conference in St. Julian's, Malta received funding from the European Union, in the framework of the Health Programme. Alzheimer Europe and the Malta Dementia Society gratefully acknowledge the additional support provided by foundations and companies.
  • European Union
 
 

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