ROANOKE TIMES 
                      Copyright (c) 1996, Roanoke Times

DATE: Wednesday, March 27, 1996              TAG: 9603270062
SECTION: NATIONAL/INTERNATIONAL   PAGE: A-1  EDITION: METRO 
DATELINE: WASHINGTON
SOURCE: Associated Press 


FIRM SEEKS FDA OK FOR ALZHEIMER'S DRUG

WHILE NOT A CURE, the drug slows the progression of the fatal disease that affects 4 million Americans.

An experimental drug appears to fight the symptoms of Alzheimer's disease just as well as the only other medicine for the fatal brain illness does, but with fewer side effects, the drug's manufacturer says.

Final testing of Aricept on 450 Alzheimer's patients found about 25 percent who took the drug for six months had meaningful improvement in memory and other cognitive skills, officials from Eisai American Inc. said Tuesday.

Based on those results, Eisai this week will file an application with the Food and Drug Administration to sell Aricept.

Aricept works essentially the same as the nation's sole Alzheimer's medicine, Cognex. But it appears to cause fewer side effects, meaning Aricept could mark the second generation of Alzheimer's therapy, said Dr. Zaven Khachaturian, director of the Alzheimer's Association's Ronald and Nancy Reagan Research Institute.

Some 4 million Americans suffer from Alzheimer's, which has no known cause or cure. It afflicts mainly the elderly, robbing them of their memories and ability to care for themselves, and eventually kills them.

The only treatment is Cognex. It doesn't slow Alzheimer's progression, but helps symptoms by inhibiting the breakdown of the brain chemical most attacked by the disease. But its effects wane, helping some patients' symptoms for just about a year, and it can cause liver toxicity and other side effects.

Aricept also inhibits the breakdown of the neurotransmitter acetylcholine. The difference is that Aricept targets only cells in the brain, while Cognex affects similar cells throughout the body, Eisai researcher Dr. Lawrence Friedhoff said Tuesday.

Eisai gave 450 patients either Aricept or a dummy pill for six months. Doctors measured the patients' cognitive ability and ability to function, using tests that usually highlight Alzheimer's patients' steady decline.

But 81 percent of the Aricept patients experienced no decline in cognitive ability or improved. One-fourth experienced meaningful improvement.

When doctors ranked daily functioning, 56 percent taking the placebo had worsened in six months, compared with 32 percent who worsened while taking Aricept.

Aricept was not tested against Cognex, but Khachaturian said the results are comparable.

Unlike Cognex, however, Aricept caused no serious side effects, including liver toxicity, Friedhoff said. The main side effect was diarrhea or other gastrointestinal disturbances.

If the FDA designates Aricept a ``priority'' drug, meaning it might help an incurable ailment, it could be reviewed within six months.

If the drug is approved, nobody knows how long patients would benefit. Eisai noted early test results from 50 patients that suggest the drug might work as long as two years.

Although patients would benefit from improved versions of the Cognex-style drugs, they will never cure the disease, explained Khachaturian.


LENGTH: Medium:   61 lines



by CNB