Clinical Trials for New Alzheimer's Medications

By Allan Vann, Huffington Post, July 19, 2016

Inside Science News Service noted on April 16, 2016 that “Alzheimer’s is a graveyard for expensive drug tests. One study showed that between 2000 and 2012, 244 compounds were tested in 413 clinical trials. Only one was approved for use, a failure rate of 99.6 percent.”

The one medication that was approved since the year 2000, Namzeric, is a medication that combines two previously FDA-approved medications, donepezil and memantine, into one capsule. But neither donepezil nor memantine are medications that effectively treat or significantly improve the lives of most people who take them. Even the third sentence on the Namzaric website reads, “There is no evidence that NAMZARIC prevents or slows the underlying disease process in patients with Alzheimer’s disease.”

Researchers have simply not been able to come up with any effective medication to prevent, treat, or cure Alzheimer’s disease (AD), but it’s certainly not for lack of trying. According to the latest data from the National Institutes of Health (NIH), there are currently 146 clinical trials testing new medication to effectively treat AD.

Researchers cannot yet agree on the cause or causes of AD, so it’s understandable that we have yet to discover a medication to prevent, effectively treat, or cure this horrible disease. Will any of these 146 medications currently undergoing clinical trials prove to be “effective” in treating AD? I certainly hope so. But I’m hoping that, if a new medication is approved by the FDA there will be abundant clinical trial evidence that supports its effectiveness. We need medication that will make a “significant improvement” for someone with AD, not another new medication that is relatively ineffective.

What do I mean by significant improvement? Medication that slows down the rate of decline to allow a person with AD to enjoy a substantially better quality of life than they otherwise would have had, for a sustained period of time, would be a significant improvement. Such improvement would be clinically meaningful in the judgment of doctors and caregivers. Sadly, clinical trial results claiming to demonstrate such “effectiveness” for previously FDA-approved medications did not meet this test.

Too many clinical trials in the past have used testing instruments to measure effectiveness that do not reflect how people with AD actually function in the real world. That is why the major 2012 Consumer Report study on AD medications concluded that most of the clinical trial evidence demonstrating effectiveness of AD medications showed improvements to be so small that they “would not be considered clinically meaningful by most doctors.”

Medication resulting in a significant delay in progression of symptoms, or perhaps temporary recovery of some previous memory loss, would be clinically meaningful. Similarly, medication which relieved AD patients suffering from severe anxiety or anger or other negative mood changes for a sustained period of time would significantly improve the quality of life for someone with AD.

If the clinical trial evidence does not demonstrate that a new medication will significantly improve a person’s ability to interact with people or the environment ... if the improvements shown by the person with AD aren’t even considered meaningful by most doctors ... then even if such medication is approved by the FDA, that medication will not provide a significant impact for people with AD or be helpful to their caregivers.

People with AD and their caregivers are already spending fortunes on FDA-approved medications that are ineffective. People with AD and their caregivers do not need any new false bottles of hope.