Washington, March 10 (IANS) American pharmaceutical Eli Lilly has stated that its solanezumab drug did not slow cognitive decline nor reduced risk of progression to symptomatic Alzheimer’s disease.
Solanezumab was designed to target amyloid protein that floats in brain fluid before it deposits on the brain as plaque.
But the trial showed that it did not clear plaque or halt accumulation of amyloid in participants treated with the drug, the drug maker said.
The results can have a significant effect on approximately 315 million people globally who have preclinical Alzheimer’s disease — the earliest stages of the disease — and have not yet shown clinical symptoms.
“The findings indicate that amyloid is a key driver of cognitive decline at the preclinical stage of Alzheimer’s disease. Solanezumab did not substantially impact amyloid plaque burden in the brain, and unfortunately did not slow cognitive decline,” said Reisa Sperling, neurologist at the Brigham and Women’s Hospital, Harvard Medical School, in a statement.
“These data suggest that we may need to be more aggressive with amyloid removal even at this very early stage of disease,” Sperling said.
Launched in 2013, the study enrolled more than 1,100 individuals between 65 and 85 years of age, from the US, Japan, Canada and Australia, who had PET-imaging evidence of amyloid plaque accumulation in the brain and who did not have clinical impairment.
Participants were randomised to either solanezumab or placebo and then treated for approximately 4.5 years.
Meanwhile, Lilly said it is developing two other Alzheimer’s treatments that are in late-stage clinical trials, donanemab and remternetug. These antibodies target amyloid plaque that has deposited on the brain and are designed to treat people who have early symptoms of the disease.
The pharma company is expecting to publish clinical trial data on donanemab later this year. The company also plans to ask the US Food and Drug Administration to approve the treatment if that data is positive.