I recently learned about the ICARA Study. The letters stand for "Investigational Clinical Amyloid Research in Alzheimer's." Here is what I know about it:
Physicians in the United States and Canada are looking for volunteers to participate in the ICARA study, a clinical study evaluating the safety and effectiveness of an investigational drug (bapineuzumab) that may help slow the progression of Alzheimer’s disease.
They are looking for men and women who:
· Are between 50 and 89 years of age,
· Have a diagnosis of mild to moderate Alzheimer’s disease, and
· Have a caregiver who is willing to be involved in the study with them.
Study participants will join more than 2,050 volunteers at 200 study sites across the U.S. and Canada. The study will last up to 83 weeks and all study-related procedures and medication will be provided at no cost. There is no charge to participate in this study. During the study, each participant will be monitored by a medical team, including a physician.
Here is what I don't yet know about it:
Who is sponsoring it? Who is paying for it? Whether the investigators are being compensated by a company that stands to profit from the results. In other words, how scientifically "pure" is the research design and control over the ultimate report of the study findings?
I don't mean to cast suspicion on what may be an incredible opportunity to participate in a significant advance in our fight against one of the main health care scourges of our times: Alzheimer's disease. But I don't know what I don't know and recommend anyone interested in participating to do due diligence before signing up.
For more information about the trial, visit www.ICARAstudy.com or call 1-888-770-6366. Also Google "Investigational Clinical Amyloid Research in Alzheimer's" and surf around. Let's hope this study will yield important results for all of us.
Bob Tell
Author, "Dementia-Diary, A Caregiver's Journal"
http://www.dementia-diary.com
3 comments:
All good points to ponder, Bob. Thanks for writing about this new research.
Thanks for your encouragement, Mary. I try to stay on top of what is happening in research. One of these days they'll crack the puzzle and Alzheimer's will go the way of polio. It's something to hope for.
Bob Tell
Author, "Dementia-Diary, A Caregiver's Journal"
http://www.dementia-diary.com
Bob you ask some good questions
"Who is sponsoring it? Who is paying for it? Whether the investigators are being compensated by a company that stands to profit from the results. In other words, how scientifically "pure" is the research design and control over the ultimate report of the study findings?"
The Bapineuzumab trial consists of four arms. Two of which are in the US and two of which are in the rest of the world. The two arms are one for carriers of the APOE4 genotype and the other is for non-carriers. The carrier arm is at a dose of .5 mg/kg and the non-carrier arm has two doses .5 mg/kg and 1.0 mg/kg. They just dropped the 2.0 mg/kg dose in that arm as the result of an interim independent safety review identifying vasogenic edema at that dose. The trials are sponsored by Elan and Wyeth. The trial centers are paid for thier sevices as with any trial. The regulatory agencies in both the US and EU are involved in the trial process and will have the ultimate say in the review of the data, therefore I think you can feel confident that the science is "pure". Just to be 100% above board here I will tell you that I own Elan shares and I came across your post as part of my due diligence of that investment.
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