Eli Lilly had recently released data from a late-stage Phase III clinical trial for an experimental Alzheimer's drug aimed at preventing the production of amyloid-beta protein — a major feature of Alzheimer's disease that is believed to cause destruction of brain neurons. This drug, however, had failed in the late-stage clinical trials. Today, the company released a webcast of its planned Phase III clinical trial of another drug, an antibody called solanezumab, aimed at seeing how well the drug works in mildly affected Alzheimer's patients.

Solanezumab binds to beta-amyloid after it is produced and supposedly blocks the aggregation of the protein. After lackluster results from multiple clinical trials in patients with a mild form of the disease, researchers decided to limit testing of the drug. The company is currently recruiting patients who are at increased risk for developing Alzheimer's, due to a known specific genetic mutation, for a clinical trial to test the effectiveness of this drug. The clinical trial has yet to start recruiting, but checking clinicaltrials.gov will allow potential trial participants to see when the trial will begin to accept patients.

While the drug had previously shown little effect in patients who were further along in their disease, the drug did slow cognitive decline by 34 percent in patients who had mild symptoms. The new trial, thus, targets patients with mild Alzheimer's and will consist of 2,100 patients, far higher than the previous two Phase III clinical trials, which each had 1,300.

The company hopes to begin enrolling patients by the end of September in the Expedition 3 clinical trial. Patients in the clinical trial will be treated for 12 months with the drug.

Eric Siemers, senior medical director of Lilly's Alzheimer's program, said that close to 25 percent of patients in the two earlier Expedition I and II trials might not have had Alzheimer's disease or amyloid-beta deposits in their brains, so solanezumab could not have helped them. Testing for the presence of amyloid-beta is more sophisticated now and can be detected by various brain scans and a spinal tap to assess free-floating amyloid beta protein to confirm the behavioral diagnosis of Alzheimer's.