Researchers Defend Japanese Alzheimer's Study

TOKYO—The scientist at the center of allegations of data manipulation in a large Alzheimer's study is staunchly defending the integrity of the data, though he acknowledges shortcomings in managing the project.

In its 10 January morning edition, the Asahi Shimbun, one of Japan's leading newspapers, claimed that researchers involved in the ongoing $31 million Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI) changed certain details of memory tests long after data were collected and that some participants were improperly included in the study.

"The Asahi story is completely fake," says Takashi Asada, a neuropsychiatrist at the University of Tsukuba who is in charge of clinical aspects of the study. In an interview with ScienceInsider, Asada explained that a standard prepublication check of data submitted to the project data center turned up suspected inputting errors—the incidents reported by the Asahi. Front-line researchers were asked to double-check their records, and corrections were made where appropriate. "This was not falsifying data but rather correcting data errors," Asada says.

A second problem that the Asahi flagged was the inclusion of patients who did not meet the study criteria. Asada says there are a few such cases, which resulted from human error. For example, he says, only patients up to age 85 were to be included, yet some older patients were enrolled in the trial either because the researchers misunderstood or didn't follow the study protocols. Data from such patients will be omitted from analyses and publications, Asada says. J-ADNI directors were discussing how to deal with data-handling problems when the Asahi story appeared, Asada says. The study’s management missteps, he says, stemmed in part from a lack of experience in handling large clinical trials in Japan.

Asada claims he was misquoted by the Asahi and says that he and his university have demanded that the newspaper run a correction. The Asahi stands by its report. "The article is based on reliable reporting," the newspaper’s public relations department wrote in a statement faxed to ScienceInsider. Despite his contention that the Asahi charges are based on misunderstandings, Asada acknowledges that they must be put to rest. The University of Tokyo, where an ethics committee approved the project protocol, has agreed to a health ministry request to investigate, though just how and when is yet to be decided, according to a public relations official at the university. "We are confident that further investigations will find no deliberate falsification in J-ADNI data," says Takeshi Iwatsubo, a neurologist at the University of Tokyo who leads the J-ADNI effort. Several U.S. Alzheimer's researchers have voiced support for their Japanese colleagues on Alzforum.

Funded by the government and a consortium of pharmaceutical firms, J-ADNI involves 38 institutions around the country. It’s modeled on the Alzheimer’s Disease Neuroimaging Initiative funded by the U.S. National Institutes of Health and several pharmaceutical firms and foundations. Asada says the Japanese effort is following the same protocols as the U.S. study, so data can be merged. One objective, he says, is to establish a baseline of Alzheimer's disease progression to test drug efficacy.