|
Home
Search
Study Topics
Glossary
|
| Study 1 of 14 for search of: | Eli Lilly and Alzheimer's disease |
|
Previous Study | Return to Search Results | Next Study |
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00762411 |
Purpose
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no known cure. AD causes brain cells to die. AD is thought to be caused by an excess of Beta amyloid (Aβ), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme γ-secretase inhibits the production of (Aβ) 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 (Aβ)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 2 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: LY450139 Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo |
| Estimated Enrollment: | 1100 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
LY450139 60mg by mouth once a day gradually escalated to 140 mg for the duration of the study.
|
Drug: LY450139
60mg orally once a day gradually escalated to 140mg orally once a day for the duration of the study
|
|
2: Placebo Comparator
Placebo by mouth once a day for a blinded period of the study.
|
Drug: Placebo
Once a day for a blinded period of time
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Show 91 Study Locations| Study Director: | Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly and Company ( Chief Medical Officer ) |
| Study ID Numbers: | 11271, H6L-MC-LFBC |
| Study First Received: | September 26, 2008 |
| Last Updated: | January 15, 2010 |
| ClinicalTrials.gov Identifier: | NCT00762411 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's Disease |
|
Neurodegenerative Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Brain Diseases |
Mental Disorders Tauopathies Dementia Alzheimer Disease |