Eli Lilly and Company has begun enrolling patients in two separate but identical Phase III clinical trials of solanezumab, previously referred to as LY2062430, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The trials, called EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries.
In 2008, Lilly began enrolling patients in two Phase III clinical trials called IDENTITY and IDENTITY 2 for a different potential treatment for Alzheimer's disease, a gamma-secretase inhibitor that also affects amyloid beta, which is believed to be one of the underlying pathologies of the disease. Patients or caregivers interested in learning how to enroll in either EXPEDITION trial or the IDENTITY trials should visit www.clinicaltrials.gov or call 1-877-CTLilly (1-877-285-4559). In combination, the EXPEDITION and IDENTITY trials will include approximately 4,600 patients with Alzheimer's disease in over 30 countries around the world.
EXPEDITION and EXPEDITION 2 - EXPanding AlzhEimer's Disease InvestigaTIONs
The EXPEDITION clinical trials are identical multicenter, randomized, double-blind, placebo-controlled trials. Patients enrolled in the trials will be randomized in a 1:1 ratio (500 patients in each trial arm) to receive intravenous infusions of either placebo or 400 mg of solanezumab once every four weeks. Patients who are taking currently available symptomatic treatments for Alzheimer's disease can continue treatment during their participation in the EXPEDITION trials. The primary objective of both trials is to test whether solanezumab will slow the cognitive and functional decline of Alzheimer's disease patients as compared with placebo. These outcomes will be analyzed using measures of the Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-COG(11)), which measures cognitive function with an emphasis on memory, and the Alzheimer's Disease Cooperative Study - Activities of Daily Living scale (ADCS-ADL), which measures the ability to independently perform daily activities such as eating, bathing, and using the telephone. Secondary objectives of the trials include different clinical benefits as measured by several brain-scanning and biochemical biomarkers and ratings scales, and quality of life impact.
"Current therapies available to treat Alzheimer's disease may help with symptoms, but they haven't been proven to change the disease progression," said Eric Siemers M.D., Medical Director, Alzheimer's disease research for Eli Lilly and Company. "Biomarker results from a Phase II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimer's disease."
EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan, and United States. EXPEDITION 2 will be conducted in Australia, France, Germany, Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, United Kingdom, and United States.
Date: May 21, 2009
Source: Eli Lilly and Company
