New clinical trial focusing on geriatric population

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The principal investigator of a new Canada-wide clinical study is not only hoping his research into a relatively new anti-psychotic medication will help his geriatric patients, but that it will also give this area of study a boost in the research arena. Dr. Kiran Rabheru, Physician Leader of the Geriatric Psychiatry Program at Regional Mental Health Care London is set to begin clinical trials into the once-a-day formulation of the drug Seroquel (quetiapine) in April 2002. While the parent drug has been on the market for a few years, the new once-a-day formulation is not, and has yet to be tested on the elderly population. If Dr. Rabheru could have it his way, any new drug used in the treatment of patients would be tested on the elderly first, instead of the usual clinical trial criteria of age range 18 to 64, which systematically excludes the older adult population. “Less than 5 per cent of clinical trials are focused on the elderly”, he says, “which is surprising given the fact that about 40 per cent of all medications on the market are used by the elderly”.

Dr. Rabheru explains that clinical trials on the elderly haven’t been conducted for many reasons including “ageism”, the medical complexity of testing medications on this age group, and the ethical issues of obtaining informed consent. However, during the past four or five years there has been some shift in attitude leading to an increased interest in the study of dementia, a disease that affects one out of three adults by the age of 80 years. Alzheimer’s disease is the most prevalent area followed by vascular and Lewy-body dementia. “As a teaching center, we’re fortunate to be able to make new medications available to our patients in clinical trials”, says Rabheru, “and this has allowed us to be involved with the development of products for patients who suffer from these very common conditions”.

Rabheru and his clinical team have been recently involved in the third phase testing of three new medications which have given hope to patients with dementia and families who struggle to cope with it. These are Ariecpt (donepezil), Exelon (rivastigmine) and Reminyl (galantamine). He explains that while these medications are not a cure for this disease, they have all been shown to affect important functional domains including cognitive, behavioral and functional. “It can be very frustrating for our patients when they can’t remember, but it’s even more frustrating for them and their caregivers when they can’t do the simple personal care routines like getting dressed.” Rabheru explains that these drugs also look promising in reducing the emergence of depression, anxiety, agitation and other behavioral complications of dementia. Additionally, one recent trial has studied and found a reduction in caregiver time by almost one hour a day that is a significant finding. “While it’s not a cure,” he says “it is a first step in terms of maintaining function for a longer period of time and reducing the burden of providing care.”

For the treatment of more severe aggressive complications of dementia, haloperidol and other typical antipsychotics are not as widely prescribed in the elderly as they once were due to the many side effects. Rabheru sites two published clinical studies using Risperdal (risperidone), which was tested by his team. These studies have lead to an official indication and widespread use of Risperdal (risperidone) for the treatment of psychosis and aggression in dementia patients. Zyprexa (olanzapine) has also been studied in this population and is a useful agent for these patients. He is enthused about the upcoming Seroquel (quetiapine) trial as this medication is likely to effectively treat the psychotic and aggressive symptoms with very few Parkinson-like side effects. London, the co-coordinating site, will be one of five test centers in Canada.

“We’re just beginning to scratch the surface in this area of research, and I’m thrilled that we’re playing such an integral role. At the end of the day, it’s all about improving the quality of lives for our patients and families.”