Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease

Summary

The purposes of this study are to determine: * The safety of LY450139 dihydrate and any side effects that might be associated with it. * How much LY450139 dihydrate should be given and how long it may be detected in blood. * To determine if LY450139 dihydrate may have an effect on a protein found in blood, called A beta. This protein is studied in subjects with Alzheimer's disease. * To collect and store samples from blood and spinal fluid for research related to Alzheimer's disease and similar (neurodegenerative) diseases or inflammation (irritation) that may provide information on how subjects respond to LY450139 or other medications. Length of study: Approximately 29 weeks. Number of office visits: 11 for most subjects: initial visit, every other week during 14 weeks of study drug treatment, and 2 follow-up visits. At no cost, approximately 45 eligible participants will receive: * Study medication * Study-related diagnostic and laboratory evaluations

Timeline

Start

2005-10

Primary completion

—

Completion

2006-12

Publications

• Portelius E, Dean RA, Gustavsson MK, Andreasson U, Zetterberg H, Siemers E, Blennow K. A novel Abeta isoform pattern in CSF reflects gamma-secretase inhibition in Alzheimer disease. Alzheimers Res Ther. 2010 Mar 29;2(2):7. doi: 10.1186/alzrt30.
• Fleisher AS, Raman R, Siemers ER, Becerra L, Clark CM, Dean RA, Farlow MR, Galvin JE, Peskind ER, Quinn JF, Sherzai A, Sowell BB, Aisen PS, Thal LJ. Phase 2 safety trial targeting amyloid beta production with a gamma-secretase inhibitor in Alzheimer disease. Arch Neurol. 2008 Aug;65(8):1031-8. doi: 10.1001/archneur.65.8.1031.

Drugs

Indications