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FDA may loosen rules on Alzheimer’s drug

The Food and Drug Administration plans to loosen the rules for approving new treatments for Alzheimer’s disease.

Drugs in clinical trial would qualify for approval if people at very early stages of the disease subtly improved their performance on memory or reasoning tests, even before they developed any obvious impairments. Companies would not have to show that the drugs improved daily, real-world functioning.

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For more than a decade, the only way to get Alzheimer’s drugs to market was with studies showing that they improved a patient’s ability not only to think and remember, but also to function day to day at activities like feeding, dressing or bathing themselves.

The proposal, published online Wednesday in The New England Journal of Medicine, could help millions of people at risk of developing the disease by speeding the development and approval of drugs that might slow or prevent it.

The proposed policy could also be a boon for the pharmaceutical industry and researchers. They have often felt stymied by regulations that left them uncertain of how to get drugs tested and approved for marketing to people early in the course of Alzheimer’s, when the medications are most likely to be useful.

Several studies are being planned for people at high risk of developing Alzheimer’s, and the proposed regulations should lead to even more clinical trials, said Dr. P. Murali Doraiswamy, an Alzheimer’s researcher and professor of psychiatry at Duke University School of Medicine.

“There is more motivation now to invest in the field,’’ Doraiswamy said. But, he added, the proposal also comes with risks.

The FDA would require companies to study the drugs after they are on the market to show they actually benefit patients.

But these studies might not be randomized clinical trials and so would not be as rigorous as the studies that led to approval.

Even with less rigorous studies, it might be hard to get the evidence, Doraiswamy said.

“A lot of companies drag their feet and never do a postmarketing study,’’ he said. Even if they do one, it may take years to find out whether a drug works. Meanwhile, millions of people may be taking it, at great expense.

The agency is trying to resolve a quandary with its new policy: How can you show a drug works if patients are so early in the course of the disease that they have no obvious deterioration in their cognitive abilities or daily functioning?

In draft guidelines to the industry last month, the agency outlined a way to resolve the problem by changing the criteria for drug approval.

Those at a very early stage of the disease, with no obvious symptoms, could be studied with cognitive tests.

Those with mild symptoms could have a combined test of function and cognition.

With the draft guidelines, the agency is soliciting comments from the public and industry and may make revisions, said a spokeswoman, Sandy Walsh.

But, she added, ‘‘we are ready to move forward with the plan.’’

Companies and researchers were elated, saying the old regulations had hobbled the field.

‘‘This is really a huge advance,’’ said Dr. Eric Siemers, senior medical director for the Alzheimer’s disease team at Eli Lilly & Co.

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