Progressive dementia (including Alzheimer's disease and related forms such as frontotemporal dementia and semantic dementia) represents an enormous health problem in Australia and worldwide. Currently, no approved medical therapies can prevent the long-term clinical deterioration caused by these conditions.
Etanercept (ENBREL) has been approved by the US Federal Drug Administration for many years as a therapy to treat inflammatory diseases such as rheumatoid arthritis. This drug has a well-characterised safety profile and has also been approved for these uses in Australia.
Recently, an ENBREL injection into a region at the base of the neck was found in studies in the US to often give marked and rapid improvements in the mental alertness and responses of dementia patients. These results have been reported in many articles now published in clinical and medical journals.
Trial Update - March 2012
We appreciate that you are anxious for the Enbrel Alzheimers trial to progress to the next stage. It is most important however, to ensure that the application to take part in the trial and all regulatory processes are approved by the necessary Government authorities prior to commencement.
The application questionnaire is currently being developed for the candidate selection process and we will be in touch as soon as the documentation is ready.
Please note that due to an overwhelming response, we do not have the capacity to respond to individual emails but will endeavour to keep our website up-to-date to keep you informed of progress.
Thank you for your continuing patience.
Trial Update - February 2012
The Griffith University Enbrel Alzheimers trial is close to progressing to the candidate selection stage. We are looking for patients with Alzheimer's disease of moderate severity without any other complicating illnesses. The application form will be circulated in the next week or so but in the meantime please be aware that there are some exclusion issues. If the prospective candidate suffers with any of these conditions they would automatically be excluded from participating in the trial. Patients will be selected for the trial based on the specific criteria.Below is a list of criteria for exclusion:
- Patient has Turberculosis, or has been in close contact with someone who has Turberculosis.
- Patient was born in, lived in, or travelled to countries where there is more risk of getting Turberculosis.
- Patient has Parkinson's Disease, Dementia with Lewy Bodies or clinically significant Parkinsonian symptoms.
- Patient has Diabetes mellitus or an immune system problem.
- Patient has Lymphoma active or in the past.
- Patient has cancer active or in the past.
- Patient has multiple sclerosis.
- Patient has demyelinating disease.
- Patient has aphasia.
- Patient has hallucinations.
- Patient has bizarre behaviour (such as violence).
- Patient is rapidly declining.
- Patient has or is being treated for infection, or has signs of infection, or is prone to infection.
- Patient has any open cuts or sores.
- Patient has or has had hepatitis B.
- Patient has heart failure.
- Patient lives or has lived anywhere there is greater risk for certain kinds of fungal infections, such as histoplasmosis
- Patient is using the medicine Kineret® (anakinra)
- Patient has developed a serious nervous disorder, seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis or stroke.
- Patient is scheduled to have surgery
- Patient is scheduled for any vaccines. All vaccines should be brought up-to-date before starting ENBREL.
- Patients taking ENBREL should not receive live vaccines.
- Patient is allergic to rubber or latex
- Patient is pregnant, planning to become pregnant, or breastfeeding.
Trial Update - January 2012
Over the next several weeks, the doctors will be receiving instruction and training to correctly administer the treatment during the Griffith University dementia trial.This will then mean that we are ready for the trial to start shortly afterwards.
We have received nearly half the required level of funding and will be starting the trial based on this support and hope that more funding will be provided. A big thank you to all of those who have helped by providing donations.
A more complete newsletter/ update will be sent out as the start date for the trial draws nearer. The past newsletters will also be placed up on the Griffiths Alzheimers Trial website shortly.
As you are registered on the site you will be contacted with information about the candidate selection process, which should commence towards the end of February.
Trial Update - Dec 2011
Thank you to all those who have emailed and/or registered on the mailing list their patient's interests for being considered for inclusion in the up and coming trial. Also, thank you for those who kindly contributed to help fund the trial as we have had little major financial support to date.
The public response has been overwhelming and we have tried to follow up and respond to all those who emailed, or phoned concerning information about the recruitment process and the timing of the study.
We know that this is a difficult and trying time for all who have loved ones with this illness. We appreciate your patience and understanding.
We are expecting to start the study in the early part of 2012, recruiting 12-15 patients ,who have particular Alzheimer's symptoms. This will be a very focussed and specific selection process and whilst all who have registered are wanting to participate in the study, as you know, this will not be possible. At the start of the trial, the 12-15 will be selected after their details are collected and relevant information for the selection criteria have been assessed by the doctors. We must give this study the best chance for success by careful selection to show whether it will work as well as it was portrayed by the doctor using this therapy in the United States of America.
This study will require several months in 2012 before we will know the success or otherwise of the therapy for Alzheimer's. We are doing our best with the limited resources and funding to get this trial underway and once we are equipped, we will then be able to proceed. However, in the event that it does prove to be successful, under our Australian criteria, it should become available from our doctors for all patients to receive as a therapy. This remains our common goal.
We will continue to update you via the mailing list and on this website, informing you of our progress as the trial unfolds next year.