Dr. Howard Fillit, Founding Executive Director and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF) shares his perspectives on the data presented today at the 12th Clinical Trials in Alzheimer’s Disease (CTAD) meeting in San Diego regarding the safety and efficacy of aducanumab as a potential new treatment for Alzheimer’s disease, particularly for people living with the early stages of the condition.
Today’s results suggest that aducanamab worked at higher doses in a percentage of the study population. More data will be needed to show the drug has a meaningful clinical effect for patients, according to Dr. Fillit.
“I believe we are at a pivotal time in Alzheimer’s research. This is not a magic bullet, but an incremental step forward in advancing the science and potentially bringing a new, disease-modifying treatment to patients.” There has been no drug approved for the treatment of Alzheimer’s in the past 20 years.
Though there are still questions about the data, Dr. Fillit noted, if aducanamab is approved, it may be effective in combination with other therapies in development.
He noted beta-amyloid is part of the story, but not the whole story – the treatment of Alzheimer’s will likely follow the path set by cancer where precision medicine via combination therapies will provide individualized and targeted therapies for patients. Dr. Fillit points to the importance of biomarkers in Alzheimer’s research and clinical trial design, as demonstrated in the Biogen study, which was one of the first clinical trials to use the amyloid PET imaging biomarker to enroll patients.
“The drug ‘hit its target’ and was able to remove beta-amyloid from the brains of patients. It was also one of the first clinical trials to ensure that every patient participating had beta-amyloid plaques, confirming their diagnosis of Alzheimer’s. The ADDF supported the first biomarker ever approved to diagnose Alzheimer’s—the beta-amyloid PET scan—and we continue to invest in these critical tools.”
“As more therapies with novel drug targets other than amyloid are developed, including inflammation, we need more novel biomarkers that can measure effectiveness. Such biomarkers will further revolutionize how we approach Alzheimer’s disease by allowing us to improve diagnosis, accelerate clinical trials and make them more efficient, and more accurately monitor response to treatment and disease progression,” said Dr. Fillit, which is why the ADDF created the Diagnostics Accelerator. The ADDF announced yesterday six new investments through this research initiative supporting the development of blood, ocular and genetic tests that will aid in diagnosis and appropriate clinical trial design for intervention and disease monitoring for Alzheimer’s disease and related dementias.