March 23, 2006
Aricept, currently approved for those with mild to moderate Alzheimer's disease, may offer modest benefits to those in the more advanced stages of the illness, researchers report. The drug appeared to reverse some of the memory loss and day-to-day deterioration seen in men and women with severe Alzheimer's disease, though the effects were not dramatic.
About one in five people with Alzheimer's have severe disease. These later, more advanced stages of the illness are a particularly stressful time for families and patients, as patients become increasingly unable to wash, bathe, communicate, and care for themselves. Many must leave the home and enter a nursing home.
The Food and Drug Administration (FDA) has approved only one medication, Namenda (medical name memantine) for the advanced stages of Alzheimer's. Aricept (donepezil) is currently approved only for the mild to moderate stages of Alzheimer's, though it is sometimes given along with Namenda for those with advanced disease. Aricept belongs to a class of drugs called "cholinesterase inhibitors," which work differently than Namenda. Other drugs in the group include Exelon (also called rivastigmine) and Reminyl (galantamine). While these drugs may cause modest delays in deterioration of memory and thinking skills in early stages of the illness, they do nothing to stop the relentless progression of the disease.
The current trial, published in the medical journal The Lancet, assessed the role of Aricept alone in severe disease. In the study, researchers at the Karolinska Institute in Sweden recruited men and women age 50 and older with severe Alzheimer's who were being cared for in Swedish nursing homes. Ninety-five were given Aricept, while ninety-nine were given a placebo (dummy pill). After six months, those taking Aricept did better on tests designed to measure thinking skills. They could also better carry out some daily activities compared to those taking the dummy pill. Side effects were similar in both groups.
"Our findings indicate that donzepezil [Aricept] can improve cognition and preserves function in patients with severe Alzheimer's disease," the authors write. "Overall, our data suggest that donepezil is an effective and well tolerated treatment, even when initiated in patients with severe Alzheimer's disease."
It remains uncertain whether costly medications such as Aricept are worth giving to people in the advanced stages of Alzheimer's disease. Indeed, studies suggest these drugs may have limited benefit even in those in the early stages of disease. [See the article, "New Study Claims Limited Benefits for Aricept".] Further study is needed. Still, the study authors believe that Aricept may be warranted in advanced disease. "If treatment can help patients in the late phase of dementia, without necessarily increasing the length of time they have severe Alzheimer's disease, then this is a treatment option that should be available," they state.
Ultimately, it is up to patients, patients' families, and their physician to decide whether a drug, or combination of drugs, should be given to those with severe Alzheimer's disease. Risks and benefits must be carefully weighed.
The current study is only one of many showing various degrees of effectiveness for drugs and other therapies. We at the Fisher Center recommend that anyone with Alzheimer's and their caregivers consult their doctors before considering any medication as a treatment option. At the Fisher Center for Alzheimer's Research Foundation, the search for more effective treatments, and a cure, continues.
Bengt Winblad, Lena Kilander, Sture Eriksson, et al: "Donepezil in Patients with Severe Alzheimer's Disease: Double-blind, Paralle-group, Placebo-controlled Study." The Lancet, published online, March 23, 2006.
David B. Hogan: "Donepezil for Severe Alzheimer's Disease" (Comment). The Lancet, published online, March 23, 2006.