The Lundbeck Starbeam Study
‘Join dementia research’ is a brand new online service, allowing volunteers for studies to be connected with researchers around the country.
We’re looking at a study that has just been added to the site, and is recruiting for volunteers now!
The study also aims to get a better understanding of the drugs safety and if it is well tolerated when given in addition to Donepezil in people with Alzheimer’s disease.
Joshua Williams is a psychologist and study co-ordinator for Starbeam.
“We have recently opened the Starbeam study in Plymouth and recruited our first patient onto the trial. The study is trailing a new drug called ‘Idaloperidin’ which has already been shown to improve cognitive performance when administered in conjunction with Donepezil – this was done in a randomised controlled trial with patients who have moderate AD.”
“It’s an international study which has recruited roughly 67 participants globally. The target is 840 but sites in the UK have only just got going, and we hope to be able to assist in reaching the global target. We are reliant on people giving their time for research in this area to progress, which is so vital.”
This study will consist of screening, treatment and follow-up phases. The study will include 7 visits to the clinic, and 1 additional visit after stopping taking the study medication. The study will last approximately 7 months.
At each visit you will be asked questions by your study doctor to assess your general state and the progress of your illness, as well as the safety and efficacy of the study medication. These will be evaluated through several kinds of scales.
As in routine practice, at every visit your blood pressure, pulse, temperature, respirations and weight will be measured. Blood (through a needle in the vein) and urine samples will be taken seven times during the study (Visit 1-7). The total amount of blood taken for these tests will be approximately 105 mL unless re-tests are taken.
An electrocardiogram (ECG) test will be done seven times during the study (Visit 1-7). During this study you will be asked to undertake some memory, language, reading, orientation and figure-copying tests. You will also be asked to answer some questions about how you feel and how you are coping in your daily life and if you are taking your medication regularly.
Your caregiver will also be asked some questions about your condition and progress. Therefore, it is extremely important this person will be able to accompany you to each visit at the clinic.
Volunteers are sought who meet the following criteria:
- The patient is a man or woman, aged at least 50 years.
- The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study.
- The patient has been treated daily with Donepezil for at least 6 months prior to the Screening visit. The dose must have been stable at 10 mg/day for the last 4 months prior to screening and throughout the screening period.
Josh concluded by saying, “Anybody wanting to take part in the study can contact their local centre, whose details are available on Join dementia research. Certainly, we would love to hear from you if you are in the Plymouth area! It’s a really exciting study and a really nice introduction to clinical trials.
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