JOAN’S BLOG – TUESDAY, JUNE 24, 2008 – ELAN INFUSION TRIAL INFORMATION – OUR FIRST DAY

Yesterday was quite the day. We had our first appointment for the Elan Infusion Drug trial. As you know, I am a scientific Dodo Bird, so my explanation will be extremely simple, but hopefully, helpful and informative to those of you who, like me, only understand scientific principles when they are SAP. I made that up – It means Simple as Possible. At the end, I will give you links to more scientific articles on the subject.

So here it is, in the most unscientific terms you will ever read, as explained to me by one of the trial doctors yesterday. The Alzheimer brain is full of amyloid plaque. Picture Elmer’s glue gumming up the brain. The idea is to find something to dissolve the glue.

There are two types of trials. One injects the patient with a vaccine that prompts the body to make its own antibodies to attack the plaque. The second is an intravenous infusion of the actual antibodies. This is the one our doctor felt was best for Sid. The antibodies bind with the amyloid (glue) and not only break up the amyloid that is there, but the subsequent infusions are supposed to attack any new amyloid plaque that tries to form. That’s the basic idea.

HOWEVER, it took 3 hours, 3 doctors, two technicians, blood work, an EKG, a shortened version of the mini-mental exam, a visit with our neurologist, and 3 packets (22 pages) of consent forms for the first screening. They emphasize that the caregiver is also an integral part of the study, in that she/he must accompany the patient to all appointments and infusions, must monitor their behavior and any changes, and must be with the patient at least 5 days a week. So, aside from reading and signing two packets of forms for Sid, I had my own packet of forms to read and sign.

We now have to wait for a call for the next appointment, which will include an MRI, extensive cognitive testing, and a lengthy interview for me. MY head was spinning when we left. The study will last 18 months, and there will be an infusion every 13 weeks. There is a 60% chance of receiving the actual medicine as opposed to the placebo. I thought –hmmm- maybe I could just leave him here and pick him up in a week, all fixed. We all need our fantasies, I guess.

Although it may sound so, I am NOT treating this lightly. The lull is over; we’re into another rough patch, so I felt the need to inject (oh, a pun – ha ha) a little humor into the situation. Now, for those of you who are more scientifically oriented that I, you can click the following links for more in depth information. Some of the articles discuss the success of Phase 2. Sid is going into Phase 3.

Elan and Wyeth Announce Encouraging Top-line Results from Phase 2 Clinical Trial of Bapineuzumab for Alzheimer's Disease

Alzheimer's Vaccination: SLU Researchers Study Giving Infusions of an Antibody to Fight the Disease

Elan and Wyeth to Initiate Phase 3 Clinical Trial of Bapineuzumab (AAB-001) in Alzheimer's Disease

Researcher's Study an Alzheimer's Disease Vaccination

Please post comments under the existing Message Board Topic: Drug Trials/Vaccine Trials. Click on the side topic "Ongoing Clinical Trials" if you are interested.

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