MedPage Today Action Points
o Note that the drug being used for Alzheimer's disease is a proprietary formulation of leuprolide.
o Explain to patients that the study is a Phase II trial that has not yet been published nor undergone peer review process.
o Also note that the results of the Phase II study were far from definitive and that further studies may be needed before treatment with the drug should be tried.
o This study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication
MADRID, July 20 -- When it comes to therapy for Alzheimer's disease, if a phase II trial isn't all that's expected, try a phase III.
That seems to be the philosophy of Voyager Pharmaceutical of Raleigh, N.C., which reported at the International Conference on Alzheimer's Disease and Related Disorders here that it is moving ahead with phase III trials of a proprietary formulation of leuprolide, the GnRH analog, despite mixed findings in a phase II clinical trial for Alzheimer's.
Clinicians found that patients appeared significantly better after taking leuprolide, usually used for prostate cancer, for 48 weeks. But they did not fare significantly better than patients not receiving the drug in critical tests of cognition - a key assessment in defining control of disease in the Alzheimer's patients.
In the pooled analysis of two studies, Christopher Gregory, Ph.D., of Voyager, noted that the primary end point of significant improvement in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was not achieved.
Although the patients on leuprolide showed a 1.87-point less decline in the scale, that difference did not reach statistical significance (P=.18). From baseline, the ADAS-cog fell 1.94 points with leuprolide; 3.81 points with placebo. Falling scores on the ADAS-cog indicate reduced cognition.
"However, we did reach our co-primary endpoint, statistical significance on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change, with 50.9% of patients unchanged or improved at 48 weeks on leuprolide compared with 34.5% of patients who were not taking leuprolide," Dr. Gregory said. "That reached statistical significance at the P=.048 level."
Dr. Gregory described the pooled results of two, placebo-controlled studies that involved 108 women and 119 men ages 65 or older with mild-to-moderate Alzheimer's. All participants in the study were already taking acetylcholinesterase inhibitors, and were stabilized on those drugs for at least three months.
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