Jan 05 2009
Aricept Study for Down syndrome Canceled
A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 has been canceled.
According to sources, Pfizer (one of the sponsors of this clinical trial) was dissatisfied with the way Phase II of this trial was being handled. It was reported that although Phase II did show some improvements within the study group, both the placebo and the Aricept groups showed improvements. Because of this, Pfizer felt that this indicated that the study was poorly-designed.
The largest problem found within the study was that the parents or guardians were responsible for completing the Vineland Behavioral Scale to record the child’s behavior and capabilities. In the initial scale rating, families reported that their child was incapable of doing simple tasks that the child could actually do, but the families just hadn’t considered. (ie: sitting for 15 minutes to focus on a task).After filling out the initial form and returning for follow-ups, the families would report that their child could complete the task that was first reported they were incapable of completing. Additionally, after filling out the initial form, families would further encourage their child to complete a task that they had not done previously. When both the placebo and study group reported a 66% increase in capabilities, this was a big sign that the clinical trial was not working.
The other factor in the cancellation of the clinical trial was that Pfizer’s patent on Aricept is about to end. Once the patent ends, generic versions will be made-thus Pfizer will not be the sole marketer and feels that continuing the funding for this project would not be a wise move considering the makers of the generic form will be taking much of Pfizer’s profits.
Families and directors part of this study both express their sadness in this cancellation of the Aricept study. Many have had positive results and have shown significant improvements upon taking Aricept. It has been reported that other evaluating tests used in this study that indicate sequencing ability and verbal expression and reasoning did show significant improvements within study participants.
Click here for more information on this clinical trial.
On a personal note: This goes to show you that your child CAN accomplish practically anything they set out to do! When Tim was 2 1/2 yrs old, the developmental therapists worried because he was “incapable” of walking up stairs. I explained to them that he couldn’t walk upstairs only because I discouraged him from doing so! He was 2 1/2 years old…. I didn’t want him to climb stairs! He climbed enough things as it was.
This study was not a failure. It showed parents that with encouragement, their child can do anything they set out to do!
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2 Responses to “Aricept Study for Down syndrome Canceled”
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My son participated in this clinical trial and we were able to see great results from Aricept!!! Yes, the Vineland seemed to be flawed to me. It asked me questions that we as a family have chosen not to expose our child to-not that he could not do it.