TORONTO -
A drug used to treat mild to moderate Alzheimer's can also ease some symptoms in people with a more advanced stage of the condition, helping patients and their caregivers to better cope with the effects of the debilitating neurological disease, a Canadian-led international study has found.
While the drug donepezil does not arrest the progression of Alzheimer's disease, the study found it improved the memory and overall functioning of those taking the medication compared with patients given a placebo.
"So it slows down what we call the symptomatic progression of the disease,'' said principal investigator Dr. Sandra Black, a neurologist at Sunnybrook Health Sciences Centre in Toronto.
Patients in the drug-treatment arm of the study showed cognitive improvement on testing and caregivers noted they functioned better overall, said Black. "They were more interactive. On the cognitive scale, they remembered things a little better, they were more attentive.''
"They were able to do some activities . . . They were able to help themselves being assisted in the bathroom. They recognized names.''
Donepezil -- sold under the brand name Aricept -- is one of a class of drugs known as cholinesterase inhibitors, which help restore levels of the neurotransmitter acetylcholine, which is greatly diminished in Alzheimer's disease.
The six-month study, published Tuesday in the journal Neurology, involved 343 people with severe Alzheimer's disease at 98 clinics in Canada, the United States, France, the United Kingdom and Australia. Half of the group were randomly assigned to receive a daily dose of donepezil, the other half a placebo.
The study found cognitive function stabilized or improved in 63 per cent of people taking the drug compared to 39 per cent of those taking placebo. All of the participants, whose average age was 78, were living in the community with caregivers.
Aricept did cause side-effects, among them nausea, vomiting and diarrhea, but in most patients they were transient.
What the results demonstrate is that there are treatments that can help people even with more advanced Alzheimer's disease, said Black.
"So I think it opens up another option for a stage of disease where people have been relatively nihilistic,'' she said. "They have felt there's nothing to be done, there's nothing that you can offer.''
"It's now suggesting that cholinesterase inhibitors can be active and can be beneficial in severe-stage disease. It gives physicians, families new options for treatment for which there wasn't clear-cut evidence before.''
Aricept had been approved only for use in mild to moderate Alzheimer's, but Health Canada gave its OK late last month for the medication to be prescribed for severe disease, based on results from this study, a 2006 paper from Sweden and a Japanese study to be published in the fall.
The problem, said neurologist Dr. Howard Chertkow of McGill University, is that most provincial governments do not cover the cost of the prescriptions when a patient is deemed "severe.'' British Columbia does not cover the costs of the drugs for any stage of the disease, a decision now being reviewed.
Aricept and its sister cholinesterase inhibitors -- including Razadyne (galantamine) and Exelon (rivastigmine) -- run about $150 to $200 a month per patient, he said Monday from Montreal.
"And I think this is going to give an evidence base for lobbying the government to extend coverage of Alzheimer's patients into the area of severe disease as well,'' said Chertkow, who was not involved in the study.
"We are not talking about medications that are curative after all, we're talking about medications that can only improve the symptoms. But can you measure things like taking the family to see the grandparent who no longer recognizes the family members and with medication they'll sometimes start to recognize the family members again?''
"It's hard to put a price tag on those things, but they can mean a lot to families.''
Scott Dudgeon, CEO of the Alzheimer Society of Canada, called the study results "great news.''
"Everybody that I've been able to speak to who has been using it or has family members who are using it see a pronounced difference that makes life more livable for not just the individual with the disease but their families and others who care for them,'' Dudgeon said.
"So to find out through Dr. Black's study that the benefit can extend to people with more severe manifestations of the disease is terrific news."