Mar 5, 2010

Pfizer Medivation's Dimebon Might Not be Dead Plus Aricept and Namenda

A second issue, will Dimebon improve behavior in Alzheimer's patients in the moderate to severe stages of Alzheimer's?....
By Bob DeMarco
Alzheimer's Reading Room

My name is Bob DeMarco, I am an Alzheimer's caregiver. My mother Dorothy, now 93 years old, suffers from Alzheimer's disease.

Like most members of the Alzheimer's community, I was greatly disappointed by this week's news about Dimebon. The results of the clinical trial showed that Dimebon did nothing to improve the cognitive abilities of Alzheimer's patients as compared to a placebo. This was the primary focus of the clinical trial. The Connection Study focused on Alzheimer's patients in the mild to moderate stage of Alzheimer's.

Let me disclose that I am not a doctor, or a scientist. In addition, my mother is currently enrolled in a Dimebon clinical trial. The adjunct drug in this study is memantine (Namenda). Go here for this study -- Identifier -- NCT00912288

Pfizer (PFE) Medivation (MDVN) has two additional clinical trials going on with Alzheimer's patients that are in the moderate to severe stage of Alzheimer's disease. There might be some good news for these patients.

Here are the key words in the Connection Study Results
The dimebon-treated group showed a 1.6 point improvement on behavior compared to placebo (p=0.17), as measured by the Neuropsychiatric Inventory (NPI). Compared to baseline, each group was improved, but this change was only significant for the dimebon group.
This scale measures behavioral problems.

There are two important components to Alzheimer's patients that come up over and over with Alzheimer's caregivers: memory and behavior. Memory and the loss of the ability to perform simple tasks like bathing and dressing are the most often discussed.

Many Alzheimer's caregivers also have to deal with bad, sometimes horrific behavior problems. More often than not these types of Alzheimer's patients end up in an Alzheimer's care facilities, rather than being cared for at home. The typical Alzheimer's caregiver is ill equipped to handle these behavior problems.

There is evidence that as Alzheimer's disease worsens so does the behavior in some patients.

So issue number one, will Dimebon slow or improve the cognition of Alzheimer's patients in these later stages of Alzheimer's disease?

A second issue, will Dimebon improve behavior in Alzheimer's patients in the moderate to severe stages of Alzheimer's?

Clearly the verdict is not yet in, and it will be quite some time before there is a verdict. This assumes that the existing clinical trials continue.

I am not trying to hold out any false hope here. The drug may or may not get approved based on the findings of the remaining clinical trials.

While we are on the topic of behavior. It is my belief that Aricept did improve my mother's behavior. I also believe it slowed the progression of the disease. However, there were other factors that were coming into play along with the introduction of Aricept. I introduced exercise, supplements, and better nutrition into the equation.

I was also able to provide lots of tender loving care, a secure environment, and I did develop many "good" communication techniques. So it could have been Aricept that smoothed out her behavior, or it could have been Aricept and the combination of the above.

Later on, we introduced Namenda into the equation. I am a strong advocate of the combination of Aricept and Namenda. If I had known what I know today, I would have put my mother on the combination of these two drugs at the very beginning -- when my mother was diagnosed with dementia, probable Alzheimer's disease. I intend to write about this again over this weekend.

I understand that some of what I am writing here is controversial. In the case of Dimebon many consider the drug to be dead. It seems to me that the verdict is not yet in. If the trials continue, I fully intend to write about our experience in the Dimebon clinical trial once we finish the 26 weeks. I understand we are only a sample of one.

In the case of Aricept, I will continue to believe what I now believe, we did benefit from the drug. Not only do I believe that it helped slow the progression of the Alzheimer's disease; my mother's behavior clearly improved after the introduction of the drug. I understand that this statement is difficult to substantiate. After all, I will never know what would have happened if my mother had not taken the drug. I stand on our experience and my observation.

I feel more strongly about the combination of Aricept and Namenda. I asked our doctor for Namenda after reading up on the combination; and because, it seemed to me like my mother was getting ready to go over the edge. The combination of the drugs made a big difference.

I have written extensively on this blog about our experience. This includes my own metamorphosis, the development of techniques to deal with my mother and Alzheimer's, communication, and advice on how we solved some of the more common problems that Alzheimer's caregivers face each day.

Go here to read some of these articles. Use the search box to find more information. The blog has over 1200 articles.

I'll close by saying this.

It is easy to vilify a drug company like Pfizer (PFE) Medivation (MDVN) when a promising clinical trial fails. Keep in mind that hundreds of millions of dollars are being spent in the hopes of finding a treatment. With each failure scientists learn a great deal. It is along this path that treatments are finally discovered.

For now we should continue to do what we do best -- Care. We can continue to hope and pray.

As always your comments and feedback are welcome.

Also see Pfizer Medivation Dimebon Connection Study Results
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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 1,200 articles with more than 9,000 links on the Internet. Bob resides in Delray Beach, FL.

Original content Bob DeMarco, the Alzheimer's Reading Room