Critical elements of leading Alzheimer’s study possibly fraudulent

Critical elements of one of the most cited pieces of Alzheimer's disease research in the last two decades may have been purposely manipulated, according to a report in Science.

Alzheimer's is the most common cause of dementia globally, according to the World Health Organization. The highly influential paper, which was published in Nature in 2006, has helped guide billions of dollars in US federal government research into Alzheimer's, according to Science.

The study, which looked at cognitive decline in mice, proposed that a specific amyloid protein may be responsible for cognitive decline. The hypothesis has since dominated the field, and researchers have worked for years to understand the mechanism by which such proteins may lead to decline.

But a neuroscientist in Tennessee, Vanderbilt University professor Matthew Schrag, said in a Science article that he and other reviewers have identified as many as 10 papers on the protein that deserve deeper scrutiny. The report also cited other prominent researchers who have had difficulty replicating results of the studies on the specific proteins.

"I focus on what we can see in the published images, and describe them as red flags, not final conclusions," he told Science, when revealing his role as a whistleblower. "The data should speak for itself."

His co-author on several papers is Dr Karen Ashe, also a University of Minnesota researcher and one of the most prominent Alzheimer's researchers in the country. She described the potential manipulation of images as "devastating," to the Minneapolis Star Tribune, but criticized the idea that her research into amyloid proteins singularly guided federal and drug company spending.

Finding a treatment for Alzheimer's has eluded scientists for decades. Although there are drugs to treat the symptoms of early and middle stage Alzheimer's, only one drug has been approved by the US Food and Drug Administration (FDA) to treat the protein plaques associated with Alzheimer's: aducanumab.

That drug, sold under the brand name Aduhelm and developed by Biogen, was the subject of its own controversy last year. As it was being considered for approval in 2021, multiple FDA officials said there was not enough evidence of its benefit to support approval.

Nevertheless, the agency approved the drug, which Biogen priced at $56,000. That prompted the resignation of three FDA officials, one of whom said there was "no good evidence the drug works".

More than 6 million Americans are believed to be diagnosed with Alzheimer's, according to the National Institute on Aging. More than 850,000 people in the UK suffer from dementia, according to the Alzheimer's Society.