Biogen announced early data on an experimental drug, aducanumab, which showed a decrease of cognitive decline in patients with Alzheimer’s disease. Aducanumab targets plaque buildup in the brain. These results were highly anticipated because of the lack of disease-modifying treatments for the more than 5 million Americans with Alzheimer’s disease.
Biogen’s continuing study to evaluate the safety and tolerability of aducanumab in patients with prodromal (ie, early symptoms that might indicate the start of a disease) or mild Alzheimer’s disease showed a reduction in amyloid plaque. Many neuroscientists believe that these plaques play a role in the progressive memory loss associated with older age. However, this hypothesis is controversial because other drugs that target amyloid plaques have been unsuccessful in clinical trials.
In the study, a total of 166 evaluable patients with prodromal or mild Alzheimer’s disease were randomly assigned to placebo or increasing doses of aducanumab for 54 weeks. Treatment with aducanumab produced a dose-dependent and time-dependent reduction of amyloid plaque in the brain. In addition, a dose-dependent statistically significant effect of slowing clinical decline was seen on the Mini-Mental State Examination and the Clinical Dementia Rating scales.
Safety was also evaluated. Patients taking the drug experienced amyloid-related imaging abnormalities, which can include edema, a potentially serious adverse event that may limit the dose of aducanumab. Edema occurred in more than half of patients in the highest dose group who had a variant of the gene APOE4, which increases a person’s risk of Alzheimer’s. In patients without the APOE4 gene, dose-dependent edema was observed in 17% of the treatment group receiving the highest dose. Headache was also reported in 22% of patients receiving aducanumab compared with 5% of patients receiving placebo and also appeared to be dose-dependent.
This study does have limitations. The study was small, and the results are from an interim analysis of data in this phase 1b study. In addition, the study was performed in patients with prodromal or mild Alzheimer’s disease.
Vice President of the Connexion Healthcare Neuroscience Center of Excellence, Dr. Nicholas C. Stilwell, spent many years as a geropsychologist diagnosing and treating patients with Alzheimer’s disease and providing guidance to caregivers. He has also consulted to pharmaceutical companies on the development of communications strategies for Alzheimer’s disease therapies. Dr. Stilwell remarked that “A treatment that modifies the Alzheimer’s disease process would provide hope that is sorely lacking with the current treatment paradigm. This is very exciting for companies with Alzheimer’s drugs in development. Strategies for new therapies have to consider many factors related to developing communications in this difficult therapeutic area.”
The Connexion Healthcare Neuroscience Center of Excellence offers executive talent with decades of experience in the pharmaceutical industry. Our team works with you to conceive a strategy and execute communications through the lifespan of your product—from drug discovery through market launch, and beyond. We will engage with you wherever you are in the development process and whenever you need us. Comprised of medical directors with scientific and clinical experience, account leads with project execution expertise, medical editors versed in neuroscience, and design leads at the top in their fields, Connexion Healthcare ensures that your objectives are met effectively and even surpassed in an industry-eloquent and compliant manner.
For further information regarding the Neuroscience Center of Excellence at Connexion Healthcare and how we can develop neuroscience communications to differentiate therapies by their unique attributes, contact:
Susan Stein, MPH
Nicholas C. Stilwell, PhD, CMPP
Neurology Center of Excellence