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FDA Approves First Alzheimer's Disease Treatment Medication

By Marlene Cimons
Los Angeles Times


The U.S. Food and Drug Administration Thursday approved the first drug for the treatment of Alzheimer's disease, a debilitating brain ailment that robs millions of elderly Americans of their memory, independence and dignity.

Tacrine hydrochloride, or THA, which will be marketed under the brand name Cognex, has been shown in two trials to provide small but meaningful benefit for some patients suffering from mild to moderate Alzheimer's.

"Tacrine is the first drug shown to have some effect on the disease's devastating symptoms," FDA Commissioner David A. Kessler said in a statement. "It is not a cure for Alzheimer's disease, but it provides some relief for patients and their families."

Its manufacturer, Warner-Lambert Co. of Morris Plains, N.J., said the drug could be available within weeks. It is expected to cost about $1,500 a year.

Alzheimer's disease is believed to afflict as many as 4 million Americans, most of them elderly. It is rare in people younger than 50, but strikes about 10 percent of those older than 65 and nearly half of those 85 and older.

It is characterized by memory loss, disorientation, depression and deterioration of bodily functions. Its cause is unknown, but symptoms are produced by the death of brain cells that secrete acetylcholine, a chemical, known as a neurotransmitter, that is essential to many thought processes.

Tacrine blocks the function of enzymes that normally break down excess acetylcholine, thereby making more of the neurotransmitter available to brain cells.

Many medical experts, however, believe the disease is under-reported, since those with Alzheimer's often die from pneumonia or cardiac arrest, when the disease is actually at fault.

The cost of care has been estimated at about $100 billion annually in the United States, according to the Alzheimer's Association.

In addition to its effect on patients, Alzheimer's also is a crushing burden for their families and other loved ones because it commonly renders the stricken individuals confused, forgetful, bad-tempered and virtually unable to care for themselves.

The agency's approval was based on studies of patients with mild to moderate Alzheimer's that showed the drug superior to a medically worthless placebo in a test that evaluated memory and reasoning ability.

"We're very, very excited: yesterday we had nothing and today we have something," said Stuart Roth, chairman of the Alzheimer's Association. "It is a ray of hope. In some cases, this drug will help patients perform daily duties they couldn't do before -- and it will also ease some of the suffering of the care givers."