Researchers Are Keeping Boomers’ Memory Problems in Mind

Dr. Eric Kandel shared last year’s Nobel Prize in medicine for figuring out what makes sea slugs remember. He’s hoping the same technology can help aging baby boomers fight memory loss.

Kandel is co-founder and scientific advisory board chairman of 3-year-old Memory Pharmaceuticals Corp., which has 20 scientists in Montvale, N.J., developing drugs based mostly on research Kandel began in the 1960s.

Aside from the research challenges, however, Memory Pharmaceuticals faces a considerable regulatory hurdle: The Food and Drug Administration has been reluctant to approve drugs that simply target normal memory problems--drugs it considers lifestyle enhancers rather than disease fighters.

“Aging isn’t a disease,” FDA spokeswoman Laura Bradbard said.

Dozens of companies large and small are racing alongside Memory Pharmaceuticals to develop drugs to enhance memory, betting the FDA will ultimately approve therapies for relatively minor memory problems.

“The fact that this is the FDA’s belief now doesn’t mean it won’t change later,” said Wally Gilbert, a former Harvard professor who co-founded Memory Pharmaceuticals and shared a Nobel Prize of his own in 1982 for contributions concerning the makeup of DNA.

Meanwhile, Memory Pharmaceuticals is also pursuing treatments for Alzheimer’s, Parkinson’s and other serious illnesses.

Americans spend about $1 billion a year on gingko biloba, a clinically unproven herbal memory enhancer. Another $1 billion is spent each year on the four available prescription Alzheimer’s drugs, each of which have shown only limited effectiveness in the 4 million U.S. sufferers. These drugs only slow the progression of Alzheimer’s, which remains incurable.

In fact, Memory Pharmaceuticals recently paid an undisclosed amount to take over Bayer AG’s research of an experimental Alzheimer’s drug, and hopes to begin testing on people sometime next year.

Still, its primary target is improving the typically failing memories of the elderly--a problem that affects about half of all seniors, said Axel Unterbeck, the company’s president and chief scientific officer.

“This isn’t cosmetic,” said Kandel, who continues his research at Columbia University. “This is a real medical problem.”

Bradbard said, however, that to win FDA approval, any drug that improves memory will also probably need to prove helpful with a major brain disorder such as Alzheimer’s.

After lobbying from a number of companies and academics, an FDA advisory committee did recommend in June that companies should be allowed to target drugs specifically for mild cognitive impairment, defined as a decline in memory function beyond what is expected in people for their age.

That memory loss disorder affects 4 million Americans, some of whom will go on to develop Alzheimer’s disease.

Any company that can successfully produce FDA-approved drugs for mild cognitive impairment will find a huge market, worth at least $1 billion a year, according to Harry Tracy, publisher of the stock-picking newsletter NeuroInvestment.

The market could become even bigger depending on whether the drugs are relatively free of side effects, making it possible to extend treatment to milder forms of memory loss.

Many companies are hoping that a breakthrough here will also lead to more effective Alzheimer’s drugs.

“Alzheimer’s is definitely one of the last great paydays for pharma,” said Bill Thies of the Alzheimer’s Assn. As baby boomers age, Alzheimer’s sufferers could number 14 million in 10 years, he said.

Pfizer Inc., Novartis, Janssen Pharmaceutica and Shire Pharmaceuticals Group are the four companies with approved Alzheimer’s treatments. Elan Corp. and Bristol-Myers Squibb Co. are conducting human testing with potential Alzheimer drugs.

Working with sea slug cells in a petri dish, Kandel discovered that when he hit one cell with a neurotransmitter called serotonin, he set off a chain reaction of molecules that resulted in the growth of new synaptic connections to the adjacent cell. This sets off a chain reaction within the adjacent cell that activates dozens of genes related to memory.

In the mid-1990s, Kandel moved from the simple neural systems of sea slugs to mouse brains, and by December 1998 he succeeded in improving the memories of mice with injections of rolipram, an experimental anti-depressant.

Other researchers improved the memories of flies with injections of the same drug. But rolipram, when used in doses large enough to enhance memory, made most of the people in studies nauseous.