Genentech, an unit of Roche Group (RHHBY.PK), said Tuesday it will be part of the first-ever prevention trial in cognitively healthy individuals who are destined to develop Alzheimer's disease because of their genetic history.
Genetech said it will collaborate with the National Institutes of Health (NIH), Banner Alzheimer's Institute (BAI), and University of Antioquia in Colombia for the trial.
According to the company, the study - the first to investigate whether an anti-amyloid treatment can stave off the disease - will span two countries and help launch a new era of prevention research in the urgent fight against Alzheimer's.
The company said the $100 million trial is the cornerstone of a new international collaborative, the Alzheimer's Prevention Initiative (API), formed to accelerate the evaluation of promising but unproven prevention therapies.
The trial will probe an experimental anti-amyloid antibody treatment called crenezumab in approximately 300 people from an extraordinarily large extended family in Colombia, who share a rare genetic mutation that typically triggers Alzheimer's symptoms around age 45.
The trial will also include a smaller number of individuals in the U.S. The API team will collaborate with researchers from the NIH-supported Dominantly Inherited Alzheimer's Network (DIAN) to identify and recruit the U.S. participants.
The trial is designed to determine whether the drug can reduce participants' chances of developing the disease's disabling and irreversible symptoms, preserve memory and thinking abilities, and slow the progression of Alzheimer's biomarkers.
The company said that if crenezumab is shown to sustain memory and cognition in people certain to develop Alzheimer's, prevention trials could be designed to test it and other anti-amyloid drugs in a larger segment of the population.
If the treatment's effects on brain imaging and other biological measurements of the disease are shown to predict its clinical benefit, the study could establish a much more rapid way to test future therapies, it added.
According to Roche, about 5.4 million Americans are living with Alzheimer's today, a number expected to top 7.7 million by 2030. Globally, the disease and other dementias are expected to affect nearly 66 million by then.
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