Experimental Alzheimer's Drug Shows Promise

April 2, 2003 -- A drug used in Germany for 10 years to treat dementia but not yet approved in the U.S. may prove to be the first medication to significantly help patients with advanced Alzheimer's disease.

Back-to-back studies presented this week indicate that patients with moderate-to-severe stages of Alzheimer's disease fared "significantly better" when treated with memantine, sold overseas as Axura. Not only did their rate of functional decline decrease, but some patients actually boosted their ability to think, move, and perform everyday tasks above levels prior to receiving the drug. Both studies are considered key to the drug's pending FDA approval, anticipated to occur within a year.

One study, published in the April 3 issue of TheNew England Journal of Medicine, found that compared with those taking a placebo, patients with moderate-to-severe Alzheimer's disease had a much slower rate of decline when given memantine.

"There was a slight initial improvement in cognitive functioning and activities of daily living in some patients. But the real benefit is that those treated with this medication declined very little over a six-month period, whereas those not treated declined pretty quickly," says researcher Rachelle Doody, MD, PhD, director of the Alzheimer's Disease Center at Baylor College of Medicine. "Symptoms may improve in some but not all patients, but this drug seems to really make a difference."

In her study of 252 patients with advanced disease, those getting 10 milligrams of memantine twice daily for seven months scored better than those on placebo in a battery of tests to measure skills that routinely deteriorate with Alzheimer's disease, such as the ability to remember and perform tasks such as eating and dressing. Though some improvements waned during the course of the study, in all categories, the memantine-treated patients declined at a much slower rate -- and had no additional side effects than those getting the sugar pills.

The other study, involving 400 advanced Alzheimer's disease patients and presented Thursday at the annual meeting of the American Academy of Neurology, shows that patients treated with memantine on top of a traditional Alzheimer's medication, Aricept, also significantly improved compared with those treated with Aricept and a placebo.

"In previous studies, the drug seemed to stabilize things -- decrease the decline that you usually see in Alzheimer's, but we weren't seeing a systematic bump on top of that," says lead researcher Martin Farlow, MD, of Indiana University School of Medicine. "In this study, clearly there was a bump above levels at the start of the study. Patients did better, and that effect persisted for the six-month period."

Farlow, who was not involved in Doody's study, says that her results add to the "consistency of data" mounting for memantine. "You are consistently seeing positive effects, and seeing them at multiple time points," he tells WebMD. "You see it in cognitive functioning. You see it in global clinical measures. You see it in activities of daily living. A caregiver will say that the patient is different -- more alert and functioning better."