Clinical Trials

1. INTRODUCTION: Older adults, particularly those with multi-morbidity, frailty or cognitive impairment, are under-represented in clinical research studies. To facilitate inclusive research for this population requires empowerment of all members of the multi-disciplinary team to promote and advocate for this underserved population. However, understanding of the personal and organisational barriers to staff engagement with research within Elderly Care remains limited.

2. METHOD: Using an amended version of the research capacity and culture tool an anonymous online survey open all staff members of an Elderly Care Department (n=351) in a District General Hospital was undertaken. The survey results were used to inform the departmental 5-year research strategy and launch a multifaceted educational and engagement programme.

3. RESULTS: 107 responses to the survey were received with a wide multi-disciplinary contribution. Despite 89% of respondents stating research was not part of their job, 96% were willing to be more involved in research. Motivators to staff engagement in research included: dedicated time for research (74%), research skills training (73%), mentors (67%), research relevant to elderly care (62%), hearing from researchers within the department (54%) and local promotion of research studies (49%). Barriers to research included: lack of time (78%), unsure of opportunities (65%) and lack of skills (47%). As a result of the survey numerous departmental interventions have been staged: a multi-disciplinary research half day, research opportunity display boards, monthly departmental presentations, promotion of the associate Principal Investigator scheme, Q&A webinars and a section in quarterly newsletter.

4. CONCLUSION(S): Multi-disciplinary staff working within Elderly Care can be motivated to advocate and engage with research opportunities for older adults. Supporting their engagement through the provision of dedicated time, research skills training and promotion of opportunities is key.

The UK Parkinson's Disease Clinical Studies Group

The UK has a successful trial scene for Parkinson’s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy neuroprotective studies, but with the growing number of trials, a formal, national structure is required to ensure the successful delivery of the studies. With funding from Cure Parkinson’s, the UK-PD-CSG launched in April-2022. The UK-PD-CSG’s goal is to further develop and support Parkinson’s clinical research across the UK and ensure more people with Parkinson’s (PwP) have the opportunity to participate in clinical trials.

The group has 65+ members, including neurologists, geriatricians, specialist nurses and Allied Health Professionals, stakeholder representatives (Cure Parkinson's, Parkinson's UK, BGS Movement Disorders SIG, ABN Movement Disorders SIG, PD Nursing Specialist Association) and PwP, all with a particular interest and expertise in PD, MSA and PSP clinical research. The group is operated by chair Professor Oliver Bandmann, Coordinator Emma Davies and co-deputy chairs Professors Camille Carroll and Tom Foltynie.

The UK-PD-CSG regular, virtual meetings provide a forum to disseminate research information, opportunities, and resources to enhance the information flow throughout research studies by establishing effective communication streams. The meetings facilitate meaningful discussion and collaboration between researchers, PwP and research organisations.

A strength of the group is the geographical spread of members, with all 18 NIHR Clinical Research Network Regions represented by at least one member. In addition to experienced researchers, the group supports individuals who are new to research to grow the number of research active sites across the UK.

The UK-PD-CSG continues to grow and works to engage more individuals interested in PD, MSA and PSP clinical research. To enable the sustained growth of the clinical trial scene, the UK-PD-CSG plays an integral, strategic role in ensuring the UK maintains and develops a trial-ready workforce and infrastructure to successfully deliver clinical research and provide more research opportunities to PwP.

Website: https://sites.google.com/sheffield.ac.uk/uk-pd-csg

X (Twitter): @UK_PD_CSG

LinkedIn:  UK Parkinson's Disease Clinical Studies Group

Instagram: @UK_PD_CSG

Author names: M Mintun1; C Ritchie2; P Solomon3; JR Sims1; S Salloway4; O Hansson5; LG Apostolova6; JA Zimmer1; CD Evans1; M Lu1; P Ardayfio1; JD Sparks1; AM Wessels1; S Shcherbinin1; H Wang1; ESM Nery1; EC Collins1; EB Dennehy1; DA Brooks1; DM Skovronsky1; TRAILBLAZER-ALZ 2 Investigators; A Farquharson (Non-author presenter)1

Author provenances: 1. Eli Lilly and Company, USA; 2. Scottish Brain Sciences, UK; 3. Boston Center for Memory and Boston University Alzheimer's Disease Center, USA; 4. Departments of Neurology and Psychiatry, Alpert Medical School of Brown University, USA; Butler Hospital, USA; 5. Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Sweden; Memory Clinic, Skåne University Hospital, Sweden; 6. Department of Neurology, Indiana University School of Medicine, USA

Introduction: In TRAILBLAZER-ALZ donanemab (DONA) cleared brain amyloid plaques, significantly slowing disease progression in early symptomatic Alzheimer’s disease (ESAD).

Methods: TRAILBLAZER-ALZ2 enrolled participants with ESAD and amyloid and tau pathology by positron-emission tomography, randomizing (multicenter) those with low/medium-tau (n=1182) and high-tau (n=552) (missing tau n=2). Participants (randomized double-blind,1:1) received DONA (n=860)/placebo (n=876) IV every 4w for 72w. DONA participants meeting amyloid clearance treatment completion criteria at 24/52w had blinded switched to placebo. Primary outcomes: Integrated AD Rating Scale(iADRS) change from baseline at 76w in low/medium-tau or combined (low/medium- and high-tau) populations. Statistical testing allocated most power (80% α spend) to low/medium-tau population outcomes, with the remainder for combined population outcomes, including clinical and biomarker assessments.

Results: In the low/medium-tau population iADRS change at 76w: −6.02 (DONA) and −9.27 (placebo) (difference 3.25; 95%CI, 1.88-4.62; P<.001), 35.1% slowing of disease progression. change in clinical dementia rating scale (cdr)–sum boxes: 1.20 (dona) and 1.88 (placebo) (difference −0.67; 95% ci −0.95 to −0.40; p<0.001), 36.0% slowing. participants receiving dona experienced 38.6% less risk progressing next stage vs placebo over 76w (cdr-global score, hr="0.61;" p<0.001). amyloid clearance at 24 />52/76w: achieved in 34.2%/71.3%/80.1% DONA-treated participants. Significant, positive results were observed in the combined population. Serious AEs: 17.4% (DONA), and 15.8% (placebo), with 3 deaths among DONA patients who experienced serious amyloid-related imaging abnormalities (ARIA). AEs with DONA included ARIA-E (24.0%, 6.1% symptomatic); ARIA-H (31.4%); infusion-related reactions (8.7%).

Conclusion: DONA treatment significantly slowed clinical progression at 76w with a safety profile consistent with earlier studies.

Presented: AAIC2023.