An experimental Alzheimer’s drug failed to slow cognitive decline in a long-awaited trial, marking the latest disappointment in a research field that has been wrought with setbacks.
Pharmaceutical giant Roche said Monday that its drug gantenerumab did not show any substantive cognitive and functional changes, including memory, problem-solving, and orientation among patients in the early stages of Alzheimer’s disease.
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“So many of our families have been directly affected by Alzheimer’s, so this news is very disappointing to deliver,” said Dr. Levi Garraway, Roche’s chief medical officer. “While the GRADUATE results are not what we hoped, we are proud to have delivered a high quality, clear, and comprehensive Alzheimer’s dataset to the field, and we look forward to sharing our learnings with the community as we continue to search for new treatments for this complex disease.”
The Swiss drugmaker held two clinical trials, each with roughly 1,000 patients in early stages of the disease across 30 countries, testing gantenerumab’s ability to slow the progression of the disease.
Gantenerumab is a monoclonal antibody treatment that targets a type of plaque in the brain made up of the protein beta-amyloid, which accumulates in the brains of Alzheimer’s patients and is thought to cause memory and cognitive problems.
Treatments for the progressive disease that has no known cure have had mixed results.
Last year, Biogen’s Aduhelm became the first new therapy for the disease in nearly two decades to receive approval after other drug candidates failed to show positive results. It has faced challenges on the market, with an initial price tag of $56,000 annually, which Biogen later cut, and Medicare limited coverage of the drug amid concerns over its effectiveness.
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Another drug candidate, lecanemab, made by Eisai and Biogen, showed promising results in reducing cognitive and functional decline in a large study among participants in the early stages of Alzheimer’s this September, improving its chances for future approval.
“We are seeing great progress and innovation in this class of treatment, and we learn from each trial,” the Alzheimer’s Association said Monday. “Each anti-amyloid treatment is being tested in a different way and may act differently on the protein that is one of the hallmarks of Alzheimer’s. Research into their effectiveness and safety must continue.”
