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Biogen Releases Clinical Trial Data for Alzheimer’s Drug at CTAD Meeting

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Clinical Trial

The interim results suggest that slowly increasing the dose of aducanumab could help reduce the risk of brain swelling, compared to administration of a consistently high dose throughout the trial period.

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December 13, 2016 | by Sarah Hand, M.Sc.

Biotech company, Biogen, presented more positive data for its experimental Alzheimer’s disease drug, aducanumab, at the 9th Clinical Trials on Alzheimer's Disease (CTAD) meeting. The drug is designed to clear beta amyloid plaques from the brains of people suffering from the neurodegenerative disease, and is currently being assessed in a Phase Ib clinical trial.

The interim results suggest that slowly increasing the dose of aducanumab could help reduce the risk of brain swelling, compared to administration of a consistently high dose throughout the trial period. The study – which involved 31 patients with early-stage Alzheimer’s – found that the drug was effective at reducing amyloid plaques in the brains of patients in the titration arm, compared to the placebo.



“The data at CTAD support the positive results we have seen in our Phase 1b study of aducanumab, and they provide insight into the observed effects in patients treated for up to two years,” said Samantha Budd Haeberlein, vice president, clinical development at Biogen. “We are committed to advancing our global Phase 3 program for aducanumab as well as the scientific understanding of Alzheimer’s disease so we can help identify a treatment for the many people affected by this terrible disease.”

According to Biogen, 35 percent of patients in the titration group experienced changes in fluid volume in the brain, compared to 55 percent of those who were given a fixed dose of aducanumab. In addition to this Phase I clinical trial, the Alzheimer’s drug is also being tested in two Phase III studies involving escalating dosing.

Patients enrolled in this Phase I trial also saw a reduction in the rate of mental decline after 12 months of treatment. These patients were characterized as having mild or prodromal Alzheimer’s disease, potentially making them more receptive to treatment compared to people with more advanced forms of the disease.

While other pharmaceutical companies – most notably, Eli Lilly – have tried to develop drugs targeting beta amyloid plaques in the brain, these drugs have largely been unsuccessful. Alzheimer’s researchers have stressed the importance of diagnosing the disease early, before the formation of significant brain-damaging plaques, so that patients have the best chance of benefitting from investigational new treatments.


Keywords: Clinical Trial, Alzheimer's Disease, Drug Development


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