Effect of γ-Secretase Inhibition on the Progression of Alzheimer’s Disease: LY450139 versus Placebo (IDENTITY)
Long Name:Effect of γ-Secretase Inhibition on the Progression of Alzheimer’s Disease: LY450139 versus Placebo (IDENTITY)
Alzheimer's disease (AD) is an incurable, fatal degenerative disease of the brain. AD is thought to be caused by an excess of A-β 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. In Phase I studies, inhibiting the enzyme γ-secretase inhibits the production of A-βamyloid 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-βamyloid and amyloid plaques for some patients. The buildup of amyloid plaques will be measured by a new type of 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. The primary purpose of this study is to help answer whether LY450139 can help patients with mild to moderate Alzheimer’s disease. The safety of LY450139 and any side effects that might be associated with it will be assessed.
Participants are currently receiving the active study medication, LY450139, or placebo (a non-active substance). Placebos are used in research studies to see if the drug being studied really does have an effect.
Up to 1500 people will be participating in this study for approximately 2 years at 148 study sites throughout the world.
LY450139 is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA).
To learn more about the IDENTITY study please call 1-877-238-4825 or visit http://clinicaltrials.gov/ct2/show/NCT00594568