Elan Vaccine and Alzheimer’s Disease Drug development

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The Roskamp Institute has a commitment to bring state-of-the-art new therapies to our patients at both the Sarasota and Tampa sites. For Alzheimer’s disease, for instance, the Institute is taking part in the Elan Wyeth clinical trials of a vaccine for Alzheimer’s disease. Important results for the Elan Wyeth vaccine were released on June 17, 2008.

The study of the vaccine called bapineuzumab (AAB-001) in a Phase II clinical trial was conducted in mild to moderate Alzheimer’s disease. The clinical trial lasted eighteen months and overall the bapineuzumab appeared to have clinical activity in treating the disease.

The company found that although the study did not attain statistical significance on the primary efficacy endpoints in the total study population, it was shown that in Alzheimer’s patients who do not carry the APO lipo protein E4 (APOE4) version of the APOE gene there were statistically significant and clinically meaningful benefits associated with the vaccine. The endpoints used included the Alzheimer’s disease assessment scale (ADAScog), the neuropsychological test battery (NTB), the mini-mental state examination (MMSE) and the clinical dementia rating scale (CDR). Interestingly too, when the company looked at brain scans of Alzheimer’s patients in the trial, they found that the MRI indication of loss of brain substance was decreased in those patients that were treated versus the placebo group.

The Roskamp Institute (Institute) is engaged in a Phase III study of the vaccine for Elan Wyeth and these encouraging results suggest that the larger clinical trial may also be beneficial. The vaccine targets are a small protein called amyloid, which researchers at the Institute believe is associated and triggers the disease pathology.

In fact, researchers at the Institute were among the first in the world to show that an accumulation of amyloid could cause Alzheimer’s disease. This they did by working with early-onset families (where the disease occurs in the 40, 50, or 60 year age groups) and showing that genetic errors in the amyloid gene were all that was responsible for the early build-up of the amyloid protein in the brain.

The Elan Wyeth vaccine is engineered to identify amyloid and remove it from the body and as such, holds potential for halting the disease progression. It is expected that the vaccine would be given every few weeks throughout the life of the Alzheimer’s sufferer.

This and other innovative treatments are available to our clinic population at the Roskamp Institute.