Despite dismal results in earlier trials, pharmaceutical giant Eli Lilly is trying again with its Alzheimer's drug solanezumab, this time focusing on patients with mild disease.
A major trial in patients with mild and moderate disease failed last summer, but the company said today that there was enough of a response in mild disease that it wants to try a narrower study focused on that population.
Maria Carrillo, vice president of medical and scientific relations for the Alzheimer's Association, an advocacy group, said she is very encouraged by Lilly's decision. The Alzheimer's community had worried last year after the failure of several very promising drugs that the pharmaceutical industry would back away from Alzheimer's drug research.
"These are encouraging times in the face of lack of positive trials," Carrillo said. "We're still continuing to fight the good fight."
To improve the chances that the drug will work this time, Lilly says it is testing more patients - 2,100 instead of 1,300 last time - and making sure that those in the new trial have signs of beta amyloid, a protein that builds up in the brains of people with Alzheimer's.
In the earlier trials, a quarter of the participants did not have beta amyloid and may have had other types of dementia instead of Alzheimer's, said Eric Siemers, senior medical director of Lilly's Alzheimer's Disease Team, in a conference call.
"We are confident this trial is significantly sized to demonstrate a difference between solanezumab and placebo," Siemers said.
Patients will receive one 400 mg. dose of solanezumab a month for about 18 months, he said. It will take some time to recruit enough patients who meet the trial's criteria. He would not speculate on how long it will take to complete the trial.
After the 80 weeks, patients can enroll in an open extension trial, where they will receive an active version of the drug, even if they were getting a placebo (inactive sugar pill) the first time.
In the earlier trials of solanezumab, there were not enough patients with mild Alzheimer's and amyloid to confirm the effectiveness of the drug, Siemers said. But there were indications that it worked in this group. More than a third showed slower cognitive decline when they took the drug, compared to a placebo, and there was some indication that their functional abilities improved as well, he said.
The drug was also shown to be very safe, he said, with few significant side effects.
More than 5 million Americans are living with Alzheimer's, a figure that is expected to nearly triple over the next generation with the aging of the population. Alzheimer's, a fatal neurodegenerative disease, includes memory loss, behavior changes and loss of independence - and therefore places a huge burden on families and other caregivers.
Karen Weintraub, Special for USA TODAY