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| Descriptive Information Fields | |||||
| Brief Title † | Effect of LY450139 on the Long Term Progression of Alzheimer's Disease | ||||
| Official Title † | Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo | ||||
| Brief Summary | Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase inhibits the production of A-Beta amyloid as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. In this trial, patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. In other words, all patients will eventually receive active drug. Each patient's participation will last approximately two years. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. All patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Rate of cognitive and functional decline in Alzheimer's disease over time. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Sometime during the study, patients originally given placebo will be given LY450139. This may help show the effect of long term treatment. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] A chemical marker of AD in the blood which may be lowered by LY450139. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] Energy usage (metabolism) seen on a brain scan called FDG-PET. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ] Brain size (volume) seen with AD on a brain scan called vMRI. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ] Amount of brain amyloid plaque seen in AD on a brain scan called AV-45-PET. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ] A chemical marker (tau) known to be elevated in spinal fluid in AD. [ Time Frame: Baseline and endpoint ] [ Designated as safety issue: No ] Safety [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ] To measure levels of LY450139 and their effect on safety, chemical markers, and effectiveness. [ Time Frame: During the study ] [ Designated as safety issue: Yes ] Quality of life. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] |
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| Condition † | Alzheimer's Disease | ||||
| Intervention † | Drug: LY450139 Drug: placebo |
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| MEDLINE PMIDs | |||||
| Links | Lilly Clinical Trial Registry  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 1500 | ||||
| Start Date † | March 2008 | ||||
| Completion Date | March 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States, Australia, Belgium, Canada, Chile, Finland, France, Germany, Israel, Italy, Japan, Poland, South Africa, Spain, Sweden, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00594568 | ||||
| Organization ID | 7666 | ||||
| Secondary IDs †† | H6L-MC-LFAN | ||||
| Study Sponsor † | Eli Lilly and Company | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Eli Lilly and Company | ||||
| Verification Date | November 2008 | ||||
| First Received Date † | January 11, 2008 | ||||
| Last Updated Date | November 18, 2008 | ||||
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