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Mixed findings for Roche in Alzheimer's study

Crenezumab misses targets but shows some signs of activity

Roche's candidate drug for Alzheimer's disease (AD) crenezumab missed its targets in a phase II trial, but showed some signs of activity in patients with mild symptoms.  

The results - presented at the Alzheimer's Association International Conference (AAIC) in Copenhagen yesterday - reinforce the notion that drugs that target the amyloid plaques that characterise AD have to be given early on in the development of the disease to have an impact.  

Crenezumab was delivered as an intravenous infusion in the phase II trial, which tested two doses of the drug against placebo in 431 patients with mild to moderate AD.  

While the overall patient group did not experience a significant reduction in cognitive decline compared to the placebo, the patients with mild disease did show a 35 per cent reduction in cognitive decline, as well as a near-20 per cent reduction in global functional decline, or the ability to perform everyday activities.  

A smaller, 91-patient study showed similar outcomes, with cognitive decline cut by 52 per cent and functional decline down 41.5 per cent compared to placebo.  

Crenezumab was licensed by Roche from Swiss company AC Immune and targets amyloid via an approach known as passive immunotherapy, binding to the amyloid beta protein that makes up plaques and stimulating the immune system to break down the clumped material.  

It works in a similar fashion to Pfizer's bapineuzumab and Eli Lilly's solanezumab, which both failed phase III trials in 2012, and so was not expected to behave differently in this study. The benefits on mild disease are encouraging however and support the role of anti-amyloid therapies early on in patients at risk of developing AD.  

Moreover, crenezumab is thought to have a somewhat milder immuno-stimulatory effect than other drugs of its type, which could make it less likely to cause inflammation in the brain and make it more suitable for long-term administration in at-risk individuals.  

"These results are an indication that AD prevention trials testing therapies in people who have … brain changes but do not yet have symptoms of dementia have the potential to be more successful than those conducted on people who already are experiencing dementia symptoms," said the US-based Alzheimer's Association in a statement.  

Crenezumab is already being tested in an AD prevention study called API-ADAT, led by the Banner Alzheimer's Institute (BAI), which has just started working on another prevention study with a dual therapy developed by Novartis.  

API-ADAT is testing Roche's drug in an extended family group impacted by early-onset, genetic AD near Medellin in Colombia.

Article by
Phil Taylor

17th July 2014

From: Research



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