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Getting Real About An Alzheimer’s Cure

Forbes article by Howard Gleckman

For decades, people have been hoping for the magic bullet that will prevent, cure, or even slow the progression of Alzheimer’s Disease or other dementias. Yet, despite small hints of progress– and billions of dollars in research–there is no drug, and no app or game, that can successfully treat these diseases.

This year, results of these efforts have been decidedly mixed. In the past month, the clinical trial of one highly-touted anti-Alzheimer’s drug failed, the Food & Drug Administration put research on two others on a fast-track review process, and the Federal Trade Commission prepared to send out company-funded rebates to customers who had been duped by a popular brain-training product aimed in part at slowing cognitive decline.

The failed drug trial, of a product developed by Singapore-based drugmaker TauRx Pharmaceuticals Ltd, targeted a protein called tau that some researchers believes damages the brains of people with Alzheimer’s Disease. For many years, researchers believed that another protein, called beta amyloid, was the main culprit. After multiple failed efforts to develop a drug based on attacking this protein, a wave of drug firms focused on tau. This trial, at least, found that a drug that targets tau in patients with early to mid-stage Alzheimer’s has no benefit.

Fast Track

Now, in an indication of how complex this effort has been, the FDA has agreed to fast-track its review of two new beta amyloid drugs. Fast tracking does not mean the drugs will be approved for use. It only means the FDA thinks they show promise in treating a serious or life-threatening disease and address an unmet medical need. One of the drugs is being developed by Biogen Inc. The other is a joint venture of AstraZeneca and Eli Lilly.

Drug companies have dozens of anti-Alzheimer’s products in various stages of clinical trials. But so far the results have been deeply disappointing. In the decade between 2002 and 2012, researchers ran more than 400 clinical trials on 244 of these drugs. One was approved for use, an astounding failure rate of 99.6 percent. No successful drugs have been developed since 2012.

At the same time, well-known apps and games that promoters claimed would slow cognitive decline have also failed. The FTC has recently cracked down on several highly-publicized “brain training” products have no real benefits. In January, Lumosity, perhaps the best known of the firms, agreed to pay $2 million in refundsto settle FTC charges that it deceived its customers.

Curiously, while research for cures and treatments has largely flopped, the incidence of dementia has been declining in much of the industrialized world. As the population ages, the absolute numbers of people with the many diseases associated with cognitive decline will rise. But the percentage of older adults with these diseases seems to be growing more slowly than in the past.

No one really knows why: It may have to do with improved education, or clinical advances in diseases such as stroke.

What are the take-aways of all this?

There are no magic bullets, and likely won’t be any for some time. Apps and games don’t work. And, so far at least, neither do drugs. There are plenty of scams. But nothing we’ve found so far will slow dementia.

We are learning from failed clinical trials, but…. The more we know about what doesn’t work, the more we can focus on what might. This is how research always works: it is slow and often frustrating. A breakthrough could come at any time, but it may take decades. And take those breathless claims that “we are on the verge of a cure” with a grain of salt. The scramble for $1 billion in federal money makes researchers hyperbolic, at best.

Congress is being myopic by boosting funding for drug research while freezing or cutting support for programs aimed at helping people with dementia and their families. They need help now, and ignoring them while throwing hundreds of millions of dollars at drug companies is cruel and irresponsible. By encouraging this strategy, the Alzheimer’s establishment must share the blame.

We must not forget that Alzheimer’s is just one of many forms of dementia. Alzheimer’s gets most of the attention and nearly all the money, but vascular dementia or Lewy Body dementia and dozens of others are just as terrible.

 

 

 

Getting Real About An Alzheimer’s Cure - overview

Summary: For decades, people have been hoping for the magic bullet that will prevent, cure, or even slow the progression of Alzheimer’s Disease or other dementias. Yet, despite small hints of progress– and billions of dollars in research–there is no drug, and no app or game, that can successfully treat these diseases.

This year, results of these efforts have been decidedly mixed. In the past month, the clinical trial of one highly-touted anti-Alzheimer’s drug failed, the Food & Drug Administration put research on two others on a fast-track review process, and the Federal Trade Commission prepared to send out company-funded rebates to customers who had been duped by a popular brain-training product aimed in part at slowing cognitive decline.

The failed drug trial, of a product developed by Singapore-based drugmaker TauRx Pharmaceuticals Ltd, targeted a protein called tau that some researchers believes damages the brains of people with Alzheimer’s Disease. For many years, researchers believed that another protein, called beta amyloid, was the main culprit. After multiple failed efforts to develop a drug based on attacking this protein, a wave of drug firms focused on tau. This trial, at least, found that a drug that targets tau in patients with early to mid-stage Alzheimer’s has no benefit.

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