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FDA Approves Drug for Treating Moderate to Severe Alzheimer's

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FORT WORTH, Texas - The Food and Drug Administration approved the first drug for the treatment of moderate to severe Alzheimer's disease Friday, giving hope to millions of people with the degenerative condition.

When used alone or in combination with other approved drugs, the drug memantine slowed the decline in awareness, reasoning and daily functioning.

"The progression of the disease is less fast, so people are able to take care of themselves longer," said Dr. Myron Weiner, vice chairman of clinical service in psychiatry at the University of Texas Southwestern Medical Center of Dallas.

It is not a huge breakthrough or cure, but it is a step in the right direction, said Weiner, an investigator in the double-blind memantine study.

Patients and their families are eager to try the drug, which has been used to treat dementia in Germany for two decades.

As soon as memantine hits the market - expected to be by early 2004 - Marie Mauldin of Bedford, Texas, said she plans to get it for her husband, Douglas, who was diagnosed with Alzheimer's in 1999.

"My husband is in the early stages of Alzheimer's disease, but we're looking for anything that can help him," she said. "I'm real excited about it. Anything like this gives you hope."

Memantine stands out from other medications used to treat Alzheimer's because it's the first drug in seven years that operates on a different mechanism, Weiner said.

Marketed under the brand name Namenda, memantine is believed to work by blocking the action of the chemical glutamate, a neurotransmitter that carries electrical impulses from one brain cell to the next.

Other drugs such as Aricept, which was approved in 1996, work by preventing the breakdown of acetylcholine, a chemical messenger in the brain that is important for memory and other thinking skills.

Although memantine only slows the progression of the disease, it's still good news for many people, said Theresa Hocker, executive director of the Alzheimer's Association - North Central Texas Chapter.

"This targets folks at a different stage in the disease process, which is something we haven't had at all," she said. "It can give temporary relief and improve the quality of life for these folks."

Alzheimer's affects about 4.5 million people in the United States. Current therapies treat symptoms, but no cure has been found. People with the disease live an average of eight years after diagnosis, but can survive three to 20 years, according to the Alzheimer's Association. In the final stages, people lose the ability to respond to their environment, speak and control movement.

Desperate for treatment, some U.S. families have turned to pharmacies overseas to get the drug, which is approved in Europe for advanced Alzheimer's disease.

This year, Glea Hale of Euless, Texas, ordered the drug from a pharmacy in Vienna, Austria, for her husband, Jim, 73. He started taking it in May, and within about 10 weeks she noticed a difference in his behavior.

"He was more independent and went on his own rather than waiting for me to suggest activities," Hale said. "He tells me he can talk better and expresses himself better."

Ordering the drug from Europe costs the Hales about $250 for a month's supply. Hale said she's thrilled to get it more easily.

"I think it keeps him a little more stable for a longer period of time," she said. "And we'll take anything we can get."

Memantine was tested in the United States in two double-blind studies involving a total of 650 people. Patients on memantine experienced less deterioration in their symptoms than those taking a placebo, according to the FDA. A third study of 155 patients in Latvia also showed the advantages of memantine over a placebo.

Researchers measured the effectiveness by evaluating attention, orientation, language, memory and social interaction. The patients' ability to eat, dress, bathe, travel, shop and perform household chores was also assessed.

The most frequently reported adverse effects were dizziness, headache and constipation, which occurred in 7 percent or less of patients.

The drug is made by Forest Labs, a New Jersey-based company that also makes Celexa, for depression, Benicar for hypertension and Aerobid, for asthma.



-An estimated 4.5 million Americans have Alzheimer's disease.

-One in 10 persons over 65 and nearly half of those over 85 have Alzheimer's. A small percentage of people in their 30s and 40s get the disease.

-A person with Alzheimer's disease lives an average of eight years and as many as 20 years after the onset of symptoms.

-More than 7 out of 10 people with Alzheimer's disease live at home.

-Half of all nursing home residents suffer from Alzheimer's disease or a related disorder.

-The average lifetime cost per patient is $174,000.

Source: Alzheimer's Association


(For more about Alzheimer's disease, go to


(c) 2003, Fort Worth Star-Telegram. Distributed by Knight Ridder/Tribune News Service.

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