Jul 19, 2010

Drug Trials Test Bold Plan to Slow Alzheimer’s -- Uh Huh

For those of you that have been here a while, I believe you enjoyed the Dotty Says articles. Those articles and those events occurred during the 6 to 18 week period when my mother was on Dimebon.....
By Bob DeMarco
Alzheimer's Reading Room

I was reading this interesting and thought provoking article in the NY Times -- Drug Trials Test Bold Plan to Slow Alzheimer’s.

The following paragraph caught my attention.

But there is a problem. The Food and Drug Administration says it needs to know not just that plaque was reduced or even that it disappeared, but that those who took a drug ended up with better memory and better ability to think and reason as compared with those who did not take the drug.

In order for a drug for Alzheimer's disease to get approved it must show that the person taking the experimental drugs ends up with a better memory than those in the control group (those that received the placebo).

This is a very elusive target. For one thing, a typical clinical trial like Dimebon only last 26 weeks. Is 26 weeks long enough to determine if a drug helped a person suffering from Alzheimer's? What if after 78 weeks the drug started showing signs that it helped? This might never get tested.

In the case of my mother. Is she a ringer when she is in a clinical trial, or just the opposite, is she the one causing the test to fail?

Here is one consideration. My mother exercises. What if more people in the control group exercise than those in the group receiving the medication? Will this effect the results of the clinical trial?

Let me put it to you this way. When I first came to Delray Beach my mother was falling constantly. I once found her lying in the parking lot shaking like a leaf. She fell and couldn't get up. There was no one around to help her until I arrived on the scene. A few weeks later she fell and broke her finger. I was at wits end.

Finally, I started taking her into the gym. She did specific exercises designed to help her strengthen her legs and improve balance. I am very proud to say this, my mother has not fallen once in almost six years years. Consider this. She was about 87 when she was falling, she is now 94.

So here is one thing we know for sure. Exercise had a positive effect on my mother. Now, there were other things going on that might have also entered into the equation. Its hard to say.

The major drug companies are focusing on memory. Are they after the right target? I'll tell you this, in weeks 6 through 18 in the Dimebon clinical trial my mother was more engaged with me, more aware of her surroundings, more interesting, and more like her "old" self then she had been in six years.

Was my mother doing better in the Dimebon clinical trial because she was on the Dimebon and also exercising? Was this an untested variable making a difference? Or, was my mother doing better because she was in a later stage of Alzheimer's disease? Why did Dimebon work for her and not for others?

By the way, I am not alone. We did have other readers that were in the Dimebon clinical trial write about their own very positive experience in the clinical trial right here on the Alzheimer's Reading Room.

What would I like to see?

More focus on behavior. Those 12 weeks in the Dimebon clinical trial were nothing less then wonderful. My mother did improve on the memory tests, however, that was the last thing on my mind.

For those of you that have been here a while, I believe you enjoyed the Dotty Says articles. Those articles and those events occurred during the 6 to 18 week period when my mother was on Dimebon. You might have noticed that the articles stopped abruptly. Why? Because my mother's behavior changed almost instantly when she stopped taking the Dimebon. When the Dimebon clinical trial was canceled.

My mother, Dotty, was no longer engaging me in the way she had been for 12 weeks. There was no longer something new, different, and interesting to write about. The world reverted to the way it was before Dimebon.

Frankly, I think there needs to be some change and some new focus when it comes to experimental drugs to help "treat" Alzheimer's disease. I am all for the cure and I hope we get there soon.

On the other hand, lets say your loved one suffering from Alzheimer's would continue to lose their memory at the same exact rate as they are right now. But. But. They could take a drug that would help them communicate better with you, make them more aware of their surroundings, change the look on their face, and improve their ability to attach with the world. Would you be interested in that type drug?

I'll vote now. Yes.

I was there for 12 wonderful, amazing weeks. So was Dotty. I'll never know if it would have been 12, 24, or 500 weeks wonderful weeks. Why? Because the clinical trial we were in -- Dimebon -- was canceled because it didn't measure up as a drug that could get FDA approval.

PS -- there was no clinical trial evidence that Dimebon was harming the 1,000 or so patients that were on the "real thing".

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Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. Bob has written more than 1,640 articles with more than 11,000 links on the Internet. Bob resides in Delray Beach, FL.

Original content Bob DeMarco, the Alzheimer's Reading Room