Positive Results from an Early-Stage Drug Trial Reported at AD/PD 2015
On Friday, March 20, positive early-stage clinical trial results for aducanumab (BIIB037, Biogen) were presented at the International Conference on Alzheimer’s and Parkinson’s Diseases in Nice, France.
There were two types of participants in the Phase 1b clinical trial: people with high levels of amyloid in their brain, and people with early Alzheimer’s disease. A total of 166 individuals were split into multiple treatment groups and a placebo group. Each treatment group received a different dosage of the drug for up to 54 weeks. The individual treatment groups were only 30-33 people each, with 40 in the placebo group.
Overall, the clinical trial had positive results. The drug had acceptable results on its primary endpoints for safety and tolerability, which is the main purpose for Phase 1 trials. Additional results showed a reduction of amyloid plaques in the brain and slowing of decline in memory and thinking abilities as well as function, the first clinical trial to show this result. Higher doses produced the most benefits. That said, this trial was not large enough, or conducted for a long enough period of time, to reliably measure effectiveness of the treatment.
An important feature of this clinical trial was the use of amyloid PET scans to identify and enroll only people with high levels of amyloid in their brains. The drug being tested is meant to clear amyloid plaques from the brain. It is therefore very important that study participants have the protein that the drug is seeking to clear from the brain. Previous drug trials have not always had an enrolled population with confirmation of amyloid present in the brain, perhaps one of the reasons it has been difficult to demonstrate effectiveness in previous Alzheimer’s disease trials.
The findings from this early-phase clinical trial of aducanumab are encouraging but additional testing is needed in larger numbers of people over longer periods of time. To that end, the company has announced it plans to move this drug into Phase III clinical trials.
Alzheimer’s Association Involvement
This trial is the first Phase 1b study to use amyloid imaging as an enrichment strategy, ensuring that all of the individuals enrolled in the study had the protein that the drug was meant to treat in their brain. The Alzheimer’s Association has been a leader in funding the discovery of amyloid PET and in establishing in its utility in the diagnostic process for Alzheimer’s disease.
Results from this clinical trial and others where the drug showed benefit in people in the earliest stages of Alzheimer’s support the idea that treating Alzheimer’s earlier in the disease process shows the greatest potential for effective treatment and prevention. This, in turn, reinforces the need for more research into early causes and biological markers for Alzheimer’s disease in order to enable early intervention.
Alzheimer’s disease is a triple threat unlike any other disease – with soaring prevalence, lack of effective treatment, and enormous costs. Congress has taken a meaningful step toward finding effective treatments for Alzheimer’s. Under the Alzheimer’s Accountability Act, Congress required the National Institutes of Health to submit a professional judgment budget to Congress every fiscal year until 2025 to help guide them in allocating funding for Alzheimer’s research.
With a robust National Plan in place to fight Alzheimer’s disease, and annual budget guidance for Congress, it is imperative that the federal government act to significantly increase funding for Alzheimer’s research. The Alzheimer’s Association calls on Congress to continue its commitment to the fight against Alzheimer’s by increasing funding for Alzheimer’s research by $300 million in fiscal year 2016.
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