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SEPTEMBER 1, 2003
"I Can't Remember" Drugs to stave off age-induced memory impairment may be on the horizon "We are who we are in good measure because of what we have learned and what we remember." -- Nobel Laureate Dr. Eric R. Kandel  The 76-year-old California lawyer appears to be the very model of healthy aging. C.L., who asked that his name not be used, hikes two miles up a nearby mountain four times a week, is always reading two or more nonfiction books at a time, and boasts that his waist and chest measurements haven't changed since he was 25. This take-charge guy expects a lot of himself. But for the past six years, his memory hasn't measured up. He occasionally forgets a name, he loses his train of thought when there are distractions, and he has walked away from six pairs of expensive sunglasses. "People who are very well-trained intellectually notice when they begin to lose that ability to grab onto every word, every concept," he says. "It's like a significant part of your life is erased." C.L. yearns for some kind of treatment -- and his determination sends a powerful message to the drug industry. Although he is functioning very well for his age, he lobbied hard to enter a clinical trial for an experimental memory drug developed by Cortex Pharmaceuticals Inc. (COR ) of Irvine, Calif. The compound, called CX516, is in Phase 2 clinical trials for people who suffer from frequent short-term memory lapses, a condition called mild cognitive impairment (MCI). It is an ominous diagnosis, even though the condition doesn't interfere significantly with daily living, because it can be an early warning sign of something much worse. Every year some 15% of people with MCI go on to develop Alzheimer's disease. HUMAN TRIALS. C.L. took nine capsules of CX516 daily for 12 weeks this spring. The impact was immediate. "At the start of the trial, I could remember less than five words out of a list of 20. By the second week, I could get 14 out of 20. There was a very, very appreciable enhancement." He has since finished his part in the study and says it was "heartbreaking" to go off the drug. "I've been thinking of some other way to get it, and I don't give a damn if it's legal or illegal." If he waits a few years, C.L. should be able to solve his problem legally. At least 60 pharmaceutical and biotech companies around the world are working on novel memory pills. Some 40 are in human trials, and the first of these could be on the market within the next few years. These drugs aim to do far more than relieve the occasional "senior moment." Neuroscientists are hoping that any pill that improves memory in the elderly will also protect against Alzheimer's disease, the diagnosis old people fear most. "Within five years, we will have treatments that slow the rate of decline or even delay the onset of Alzheimer's by five years or more," predicts Dr. Leon J. Thal, chairman of the Neurosciences Dept. at University of California-San Diego. The drug industry is spending billions of dollars to come up with such a pill, and it's not hard to see why. In 10 years, all 77 million baby boomers will be 50 or older, and as many as 25% of them may develop some form of dementia. They do not, however, show any interest in going gently into that good night. As Harry M. Tracy, publisher of the newsletter NeuroInvestment, notes: "This is a generation that does not accept decline." FINAL FRONTIER. It's also a generation that is approaching the danger zone. The brain reaches its maximum weight by age 20 and then slowly starts shrinking, losing 10% of its volume over an average lifetime. It's virtually inevitable that mental glitches will show up by the time we are eligible for senior-citizen discounts, and people are noticing. Surveys have found that 75% of people over 50 believe they suffered memory problems over the prior year. Some of these people may be overreacting -- but a large proportion aren't. At least 20 million Americans over 60 have some level of memory impairment short of dementia. Another 4.5 million are victims of Alzheimer's, a progressive brain disease that over the course of a decade destroys memory and other cognitive functions until its victims are virtually helpless. The longer one lives, the greater the danger -- 50% of people age 85 and over end up with Alzheimer's. Since more of us are living to an old, old age, trend lines for memory loss all point upward. The Alzheimer's Assn. estimates that by 2050 -- when the number of people over 65 will have doubled, to 70 million -- there will be 13.2 million Alzheimer's victims. Run the numbers, and it's obvious that a pill that promises to protect against this terrible malady would dwarf the $1.7 billion a year pulled in by Viagra, that other salve for an aging body. That such pills are even in the pipeline is something of a scientific miracle. The human brain is medicine's most daunting frontier. Made up of more than one trillion highly complex neurons, it remained obdurately opaque long after the body's other tissues had given up many of their mysteries. But in the past decade, the code has been partially cracked. Using sophisticated imaging technologies, animal experiments, and genetic insights, scientists now have a road map of the complex process that is memory formation. Products follow knowledge. The first drug able to improve the thinking abilities of people with advanced Alzheimer's disease was approved in Europe last year and is widely expected to win the nod from the Food & Drug Administration this fall. Memantine, developed by the German company Merz, is no miracle cure, and it has shown no effect in Alzheimer's patients in the earliest stages of the disease. But clinical trials demonstrated that the drug allows the most desperately confused patients to live independently for six months to a year longer than they would otherwise, with no debilitating side effects.
Memantine is a smart bomb by comparison. It targets a cell receptor that controls the intake of glutamate, a neurochemical that scientists believe is responsible for 75% of the communications between brain cells. "Memantine represents real progress, a meaningful therapeutic advance," says Dr. Pierre Tariot, a University of Rochester psychiatrist. Neuroscientists eagerly anticipate more such advances. Even now, the contours of an enormous memory industry are coming into view. Just look at the herbal supplement ginkgo biloba: Annual sales reached an estimated $500 million in the U.S. last year, although clinical trials have disproved claims that it can boost memory. The three Alzheimer's drugs now available had combined U.S. sales of more than $1 billion, despite their shortcomings. Memory clinics are springing up around the nation, headed by everyone from top-ranked neurologists to New Age practitioners, while bookstore shelves are stuffed with how-to guides on memory maintenance. A CURE IN CURRY? Even the federal government is in on the act. The cost of caring for Alzheimer's victims in the U.S. will total over $100 billion this year, making the disease a top priority of the National Institutes of Health. It is sponsoring a dozen or more clinical trials of potential memory enhancers in the hopes that something, anything, will be found that can delay the slide into dementia. Anti-inflammatory treatments such as aspirin and Celebrex are particular favorites for study, because inflammation in the brain is a hallmark of Alzheimer's disease. Vitamin E also has attracted interest in the hope that it may protect brain cells from damaging molecules called free radicals that course through the blood and batter healthy cells. 
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