May 17, 2010

The Dimebon Experience -- Sunshine's View

The more I think about it, the angrier I get.....
Sunshine wrote:

Many of us feel our loved ones have done better on Dimebon (Pfizer (PFE), Medivation (MDVN)). Mine was in the safety study that Pfizer trumpeted as having been so successful, at the same time they had to report that the CONNECTION study was a failure.

The more I think about it, the angrier I get.

This is the double-blind, placebo-controlled study we were in -- A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

It's the safety study that Pfizer announced had shown such excellent results, at the same time they had to announce that the CONNECTION study had failed to show statistically significant benefits.

Note that the "Purpose" section says, "After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study."

The Informed Consent form that we signed said, "If you complete the study and the study doctor thinks you are benefiting from treatment with Dimebon the sponsor will continue to provide Dimebon until it becomes commercially available or the sponsor discontinues its development."

We live in an area where there are many clinical trials for promising new Alzheimer's drugs. One of the key reasons I chose the Dimebon study was because it offered the open-label extension to those who completed the double-blind, placebo-controlled study.

The double-blind, placebo-controlled study transitioned into this open-label study: which is what we're in now.

The Informed Consent form that we signed said, "The exact duration of your participation in the study is not certain because the study Sponsor (Pfizer) intends to have Dimebon be available to you until it is available commercially and you can buy it in a pharmacy. Therefore, if you agree to be in this study, you will take active study drug for about 2 to 3 years until the study drug becomes commercially available ..."

Pfizer verified on the site that the open-label study was still recruiting on May 4, 2010. One week later, on May 11, they pulled the plug.

We were in the 3-month cohort on the double-blind, placebo-controlled study. Our first session was in late June 2009. I was always sure that my husband was on the drug. For one thing, the trial people gave him his very first pill at the end of the first session, about mid-afternoon. He hadn't had anything to eat since breakfast, and quickly became nauseated and was clearly in distress, complaining of "pressure" and heartburn. I was always careful to give him the dimebon after a full meal, after that, and he did not have any more problems.

For another, I could see changes. In mid-August, I mentioned to our study coordinator that I was sure my husband was receiving Dimebon, and he commented that two of the other participants in the trial appeared to him to be getting better -- they were speaking more easily. That was one of the changes I had noticed in my husband, but had not mentioned to the coordinator.

We transitioned into the open-label study in late Sept 2009.

As for the changes I was seeing ...

In June, just before we started the Dimebon study, if I took my husband to meet a friend for lunch, he would be anxious about going, be bewildered by the menu and ask me to choose his meal and order for him, would refuse to eat anything after the food arrived, was uncomfortable talking, and suspicious as to my friend's motives for wanting to see me. One friend arranged a special tour for a small group of us, at the zoo. My husband had met this friend once before, at lunch (behaving as I just described).
My journal comments:
"He acted as if he remembered my friend, although he was uncomfortable talking to her, but started to get uptight about the others, and was confused and had some trouble walking, and wanted to lag behind everyone. ...We wandered into the tiger exhibit. It was too dark, and too many people, and he started getting claustrophobic. ...I don't know if he enjoyed the tour when we finally got started -- we were within arm's length of a massive male Siberian tiger, and then a female. That went OK, but when we were allowed to look through a screened/curtained window to see two cubs and their mother, he wouldn't get close -- too claustrophobic again, and he didn't want to be near anyone else."

I decided to leave, because I was getting increasingly concerned about my husband's discomfort. We said goodbye to the group. My journal continues, "On the way up out of the canyon, he walked so slowly and seemed so confused, I thought we were in for a serious problem. We went up the moving walkway; he got on both sections OK but had trouble dismounting from both. He wasn't interested in the exhibits on the way out as he was last time [several months ago]."

In late October (one month into the open-label study, four months on Dimebon in my opinion), the same friend arranged for a tour for another group -- again, people we had never met -- and was again kind enough to include us.

My journal says,
"He was friendly with all members of the party, attempted to strike up conversations with my friend (who he did clearly remember) and the other two women. (He was not too sure who JN's husband was, and the husband was a wee bit stand-offish). BK flirted outrageously with him, and he flirted right back. Showed no signs of claustrophobia... Was willing to get close to the exhibits most of the time, posed with my friend and BK for pictures. He handled the tour of the tiger exhibit much better than the first time. My friend commented that he seemed much more alert than he did the first two times she met him."
He had no trouble walking out of the canyon, and we lingered at many exhibits along the way. We went to a restaurant for lunch, and he selected what he wanted from the menu and ordered for himself.

An email to my friend five days later: "His brain seems to be functioning better when it comes to memory, planning ahead, understanding events etc. For example, after we left you-all, he said he knew who the three ladies were, but wanted to know "how that guy fit in."

He wanted me to buy him cookies the last time we were in a grocery store -- something he hasn't done in many months -- and he not only remembered we'd bought them, but figured out where I put them and helped himself when he got hungry -- something else he hasn't done in forever.

He offered to get dinner started for me the other evening lol. I suggested that he root around in the refrigerator and pick out what he'd like to have, which he did. In months gone by, he's gotten agitated over making a decision between two choices that I've offered him.

This is what Pfizer is taking away from us -- after they promised they would continue to give us Dimebon if my husband did well on it.

According to our study coordinator, "Pfizer states they feel that it is not in the best interests of subjects to continue them on Dimebon when they are not sure if it is effective" -- because of the Dimebon CONNECTION trial data, not because of what Dimebon has done for the "subjects" and what was found on the previous clinical trials -- and that they will not "know" if it is effective for another 1.5 to 2 years, when the Dimebon CONCERT study is completed and the data analyzed. (Editor note: As of May 15, 2020, the study is still recruiting participants.)

If you ask me, Pfizer is trying to cut costs, and doesn't give a hoot what is in the best interests of "subjects". They say that the data from the Phase III safety trial showed Dimebon is very safe and well-tolerated, so how can leaving my husband -- and many hundreds of other "subjects" like him -- on Dimebon for the next 1.5 to 2 years do any harm? That's the length of time we were expecting to be on it in this study, to begin with. And what is going to happen to our loved ones when the drug is taken away from them? Is that going to be in their "best interests"?

Bob, Pfizer doesn't even intend to let us finish the allotment of pills that we already have. They want us to go in for an exit examination next week, and turn over any pills we have remaining in our possession. (In case you're wondering, that isn't going to happen!)

I figure if we can get some media attention, the story could go either of two ways.

(1) Good PR for Pfizer, in that study participants firmly believe the med has helped their loved ones.
Or (2) very bad PR for Pfizer, in that they chose to save a few bucks rather than live up to their promises to study participants -- with possibly devastating results to those participants.

Not to mention, I'm surely not the only person who based my decision to enroll in the Dimebon trial, as opposed to one of the many other clinical trials here, on whether we'd be in an open label phase once we'd made it through the double-blind phase.

If Pfizer gets a reputation for breaking their word, they just might have more trouble getting people with any type of disorder to enroll in one of their trials.

Editor Note: these are the opinions of a reader that was enrolled in a Dimebon clinical trial. They are not employed by or affiliated with the Alzheimer's Reading Room. Name withheld upon request.

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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 1,400 articles with more than 9,000 links on the Internet. Bob resides in Delray Beach, FL.

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