What is most compelling is that more amyloid was cleared when people took higher doses of the drug. The team conducted a one-year long treatment with the antibody for a phase 1b study, resulting in almost complete clearance of brain amyloid plaques in the 165 patients studied who had early-stage Alzheimer’s disease.
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This trial size was small and was primarily meant to assess the safety of aducanumab in humans. Although not initially planned as a primary study objective, the good results encouraged researchers to additionally investigate how the treatment affected the symptoms of disease.
So with that in mind, here’s what happened.
Professor Paul Morgan, Director of Cardiff University’s Systems Immunity Research Institute, said: “Our research proves that it is possible to predict whether or not an individual with mild memory problems is likely to develop Alzheimer’s disease over the next few years”. This idea is known as the amyloid hypothesis.
The second one is its ability to enhance the capabilities of immune cells in the brain of patients to remove toxins such as amyloid.
Overall, Alzheimer’s researchers are urging caution about the new drug results-even those who are co-authors on the paper.
The results of the trial, which Biogen has revealed in pieces at previous scientific conferences, shows that the higher the dose of the antibody, called aducanumab, the more amyloid is removed.
After 54 weeks of treatment, scans showed that levels of beta-amyloid had been significantly reduced in the brains of patients given the drug.
The red represents amyloid-beta plaques. The treatment is thought to target aggregated forms of amyloid-beta, including soluble oligomers and insoluble fibrils, deposited into the amyloid plaque in the brains of AD patients.
The article includes a powerful image of the brain scans, which show the effects of the drug in eliminating plaques. “That is a very striking and encouraging finding and a major advance”.
Currently, there is no effective therapy for Alzheimer’s that disease causes nerve cell death and tissue loss throughout the brain.
The team, which published the study in the Sept 1 issue of Nature, has 125 patients with early symptoms of Alzheimer’s disease in the randomised, double-blind placebo-controlled study.
Alongside the study is the question of whether the drug will have a long-term impact on cognitive function. The different dosages of aducanumab being tested are shown on the right. These trials are expected to last until at least 2020.
“These results are the most detailed and promising that we’ve seen for a drug that aims to modify the underlying causes of Alzheimer’s disease”, James Pickett, head of research at the Alzheimer’s Society, who was not involved in the study, told Ian Johnston at The Independent.
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“The results of this clinical study make us optimistic that we can potentially make a great step forward in treating Alzheimer’s disease”, Nitsch concluded.
