Tallaght Hospital is Leading the Irish Phase of a Global Trial for a Potentially Transformative New Medicine

Research Team Alzheimer's (November 24th 2016) Tallaght Hospital has recruited the first Irish people who will take part in a global trial aimed at preventing Alzheimer’s disease. The Hospital is conducting the Irish phase of this global clinical trial, which is a significant milestone for Alzheimer’s research at the Hospital.

The trial will focus on the newly developed drug, Verubecestat. This tablet has been shown to “switch off” the production of the protein amyloid in the brain which is thought to be the chief cause of Alzheimer’s disease. Importantly, amyloid accumulation in the brain can precede the onset of symptoms of Alzheimer’s disease by several decades. Therefore, participants in the MSD trial have been selected based on having mild memory difficulties but without the presence of Alzheimer’s, as memory difficulties can indicate this amyloid accumulation. Screening for participation in the trial involved the first ever amyloid PET scans ever to be performed in Ireland.

The Chief Investigator for the Irish leg of this trial is Dr. Sean Kennelly, Consultant Physician in Geriatric & Stroke Medicine at Tallaght Hospital, as well as Clinical Senior Lecturer in Medical Gerontology, Trinity College Dublin. Commenting on the trial he said: “This is a key milestone, for the first time Irish people who have memory difficulties but haven’t yet clinically developed Alzheimer’s disease have the opportunity to participate in a trial of a medication which could potentially delay or halt progression of their symptoms. This medication targets brain accumulations of the protein amyloid which most researchers believe is the primary cause of Alzheimer’s disease. Alzheimer’s is a progressive, degenerative disorder and with a high projected growth in older persons over the next 20 years it is a disease that is most likely to continue to increase. Causing great distress to those diagnosed and their loved ones, increased diagnosis also has a massive impact on care needs in the acute hospital setting and in our communities. The fact that the trial medication in question is a once a day tablet is also encouraging. This is a very exciting time for Alzheimer’s disease research with several treatments showing early promise, having said that we must remain cautious as there have been many false dawns in this field.

Galway University Hospital will also be participating in the study over the coming months under the leadership of Principal Investigator Dr. Ronan Ó Caoimh. There was very high interest in participation, both in Ireland and globally, and enrolment for screening for recruitment has already been completed; the last patient is expected to be randomised in January 2017. This means that the study is closed to any further participants.

Tallaght Hospital has developed several high quality supports and services for Alzheimer’s and Dementia research, including the Hospital’s weekly Memory Clinic. Launched earlier this year it offers a multidisciplinary service incorporating geriatric medicine physicians, clinical nurse specialists, clinical neuropsychologists and occupational therapists among others, aiming to identity those most at risk of Dementia as early as possible. Dr. Sean Kennelly established the clinic with his colleagues and contributes to the Memory Clinic as a Consultant Geriatrician.

Verubecestat is produced by MSD and the trial has been welcomed by the Alzheimer Society of Ireland. The Society has also welcomed the launch of the clinical trials, as the publication of the results of early stage clinical trials have shown that it successfully targets the more visible sign of the disease within the brain. If licenced, this treatment could be the first to be approved for Alzheimer’s disease in over a decade.

Welcoming the announcement Emer Begley, Policy & Research Manager with The Alzheimer Society of Ireland said: “We are thrilled that Ireland is getting the opportunity to participate in global trials for the first treatment to halt or reverse Alzheimer’s disease. It has been over a decade since a new drug was licensed for the treatment of dementia, so we urgently need new medicines that can provide real benefit for people living with the condition. There is a wave of potential new treatments currently being tested for dementia, which is so heartening, and we hope that our talented Irish researchers are provided with adequate resources and funding to play a key role in the progression of this potentially life changing research into the future.”

Dr. Colm Galligan, MSD Medical Director said,"Alzheimer's disease is the most common form of dementia, characterised by progressive loss of cognition - our ability to learn, remember and plan our lives. Right now there are approximately 48,000 people in Ireland suffering from Alzheimer's and that number is set to increase as the population ages. This disease impacts many families around the country well beyond the patient, and current therapies are limited so there is a great need for understanding as to how Alzheimer's disease develops, and what the underlying processes are in order to develop effective treatments. Alzheimer's also impacts many families beyond the patient with approximately 50,000 family carers in Ireland today.  We are delighted that we can contribute to the fight against Alzheimer's, a disease that has such a dramatic impact on people's lives and others in the community."

For more information on the clinical human study trials, reference the following website: http://www.merck.com/clinical-trials/study.html?id=8931-019

About Dr. Sean Kennelly MB PhD FRCPI 
Dr. Sean KennellyDr. Kennelly is a consultant physician in geriatric and stroke medicine and director of the memory assessment clinic in Tallaght Hospital, Dublin. He is a clinical senior lecturer in the department of medical gerontology Trinity College Dublin, and a principle investigator in the Trinity College Institute of Neuroscience. His primary research interest is Alzheimer’s disease and other neurocognitive disorders of ageing. He was co-principle investigator on the first Irish National Audit of Dementia (INAD) care in acute hospitals. He is chief investigator in the Irish arm of the APECS Verubecestat study in prodromal Alzheimer’s disease. He is the Scientific and Medical Advisor on the EU FP-7 funded NILVAD project. He is the national specialty director for the specialty of general internal and acute medicine for the Royal College of Physicians in Ireland. He is also a member of the clinical and research advisory panel for the Alzheimer's Society of Ireland and honorary secretary of the Irish Society of Physicians in Geriatric Medicine.

About Tallaght Hospital
Tallaght Hospital is one of Ireland’s largest acute teaching hospitals, providing child-health, adult, psychiatric and age-related healthcare on one site. The Hospital has 495 adult beds and 67 paediatric beds, a staff of 2,600 people and an annual gross budget in excess of €0.25bn. The Hospital is a provider of local, regional and national specialities. It is a national urology centre, the second largest provider of dialysis services in the country and a regional orthopaedic trauma centre.

Tallaght Hospital is a major teaching hospital of Trinity College Dublin - specialising in the training and professional development of staff in nursing, health and social care, emergency medicine and surgery, amongst many others. The Hospital is part of the Dublin Midlands Hospital Group which serves a population of over 1.2 million across seven counties.

A new satellite centre is to be built at Tallaght Hospital as part of the New Children’s Hospital project and will be a key element of an integrated clinical network for paediatric services nationally.

The Hospital’s Emergency Departments catered for 45,551 Adult Attendances and 32,272 Paediatric Attendances in 2015. A further 206,169 patients were treated through the Hospital’s outpatient clinics in 2015. The Hospital’s operations are supported by 200 general practitioners in surrounding communities. Ends