April 7, 2014
The drug maker Eli Lilly is proceeding with trials of an experimental drug called solanezumab to treat early Alzheimer’s, despite earlier research in which the drug had failed to meet study goals. In earlier research the drug had shown hints of promise for those in the earliest stages of the disease.
The new trial will enroll 2,100 patients with early Alzheimer’s, larger than previous trials. Patients will be tested for beta amyloid, the toxic protein that builds up in the brains of those with Alzheimer’s, to confirm that they likely have the disease.
Researchers are hoping that the drug may be effective in those with the mildest forms of Alzheimer’s. Earlier research showed it had little or no effect in those with more advanced disease, in which brain damage is already extensive. It was also ineffective in those with forms of dementia other than Alzheimer’s.
In separate studies, solanezumab is being tested to prevent early-onset Alzheimer’s in those with a gene that causes the disease to appear at a young age. The large new trial will test the drug for treating the far more common late-onset form of the disease, which typically strikes those over 65.
In the study, half the patient will get solanezumab, which is administered through an I.V. injection, and half will get a placebo. Patients will get a 400 milligram dose monthly for 18 months. The study is expected to take up to two years to enroll patients and likely several years to complete.
The decision to proceed with further study of solanezumab underlines the lack of effective treatments for Alzheimer’s. Currently available drugs for Alzheimer’s can ease symptoms but do not stem the inexorable decline of the disease. Unlike those drugs, solanezumab is designed to halt disease progression and preserve thinking and memory skills.
It is one of a several drugs under investigation aimed at beta amyloid.
There is no guarantee of success. Other drugs have shown promise in early trials, only to show no effectiveness in larger late-stage studies.
Source: Eli Lilly drug company.