Major Alzheimer’s drug candidate fails test: What was the Roche trial

The statement said that the twin studies, known as Graduate 1 and 2, had not reached their main goal of showing that the drug gantenerumab could preserve abilities such as remembering, solving problems, orientation and personal care in patients suffering from early stages of Alzheimer’s disease.

The Swiss drugmaker conducted two identically designed studies, each with about 1,000 participants, who were examined and queried by physicians over more than two years. Within each study, volunteers were randomly assigned to receive either the injectable antibody drug gantenerumab or a placebo.

The drug was associated with a relative reduction in clinical decline of 8 per cent in Graduate 1 and 6 per cent in Graduate 2 compared with the placebo, but those results were not statistically reliable, the company said in a statement.

Gantenerumab was designed to bind to aggregated forms of beta-amyloid and remove brain amyloid plaques, which are believed to play a crucial role in the slowly progressing dementia disease.

Roche released only the main outcome of the trials on Monday. It plans to present detailed data at the Clinical Trials on Alzheimer’s Disease conference in San Francisco on November 30.

Rachelle Doody, Roche’s head of neurodegeneration, said she was very disappointed, adding that trial measures of amyloid removal were also lower than hoped.

“We will be showing that there is a relationship between the lowering of amyloid and the clinical outcomes. It’s just that when you don’t get the amyloid lowering that you expected you won’t get the clinical outcome that you expected,” she told Reuters.

Alzheimer’s threat

Most of the 55 million people suffering from dementia worldwide are likely to be affected by Alzheimer’s disease, according to the World Health Organisation. In 2030, dementia is expected to affect 78 million.

Alzheimer’s is difficult to diagnose, especially during its early stages.