The Alzheimer’s Association is disappointed by the topline Phase 3 data reported today by Genentech and Roche from the GRADUATE Phase 3 global clinical trials of gantenerumab. However, these results will contribute to our understanding of this devastating and fatal disease. Although the drug did not meet its primary endpoint, the trials further illustrate the relationship between removal of beta-amyloid and reduction of clinical decline.
We are seeing great progress and innovation in this class of treatment, and we learn from each trial. The GRADUATE trials were well-powered and fully-completed Phase 3 studies that will help us learn more about the impact of removing beta-amyloid on slowing clinical decline for people living with early stage Alzheimer’s. These results, along with the positive reported data for lecanemab and FDA-approved aducanumab, are valuable for clinicians and researchers.
Each anti-amyloid treatment is being tested in a different way and may act differently on the protein that is one of the hallmarks of Alzheimer’s. Research into their effectiveness and safety must continue. It is important to evaluate each new treatment independently. We look forward to learning more about the GRADUATE trials at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting later this month.
There were several innovative aspects of these gantenerumab trials. For example, the treatment was delivered by injection under the skin rather than an infusion directly into a vein, and the drug was administered with half the dose delivered twice per month, rather than the whole monthly dose given at one time. These features could make it possible to have a more accessible and affordable treatment that can be administered in a doctor’s office and perhaps even at home. The hope is that this method, which is also being tested in other treatments, will be just as effective, more convenient and reduce potential travel-related hardships on people living with Alzheimer’s, their caregivers and family members.
The global GRADUATE trials included local study sites in 32 countries, and we look forward to learning more about the representation in the trials in the coming weeks. It is imperative that clinical trials do more to reflect the global population and those most impacted by Alzheimer’s disease.
The Alzheimer’s Association and the Alzheimer’s Impact Movement (AIM) support the bipartisan Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act (S. 1548 / H.R. 3085). The ENACT Act would provide resources to increase the participation of underrepresented populations in NIH-supported Alzheimer’s and other dementia clinical trials, expand education and outreach to these populations, and encourage better racial/ethnic representation among clinical trial staff.
More and better options for treatment are desperately needed for people living with all stages of Alzheimer’s disease. The Alzheimer’s Association is confident about the robust and diverse Alzheimer’s drug development pipeline. The unprecedented number of Phase 3 clinical trial data reports and anticipated Food and Drug Administration (FDA) actions over the next year clearly signal that we are in a new era of expanding possibilities for Alzheimer’s disease treatment.
The future of Alzheimer’s treatment will be a combination of drugs that target different aspects of the disease at different times, as well as lifestyle interventions. Encouraging and supporting a diverse treatment pipeline is essential to achieving the Alzheimer’s Association’s vision of a world without Alzheimer’s and all other dementia.
We know that current anti-amyloid approaches are not a cure, nor will they stop the disease on their own, but they are the first wave of effective treatments for Alzheimer’s, with more to come. The Alzheimer’s Association is committed to advancing all potential treatment avenues, and exploring combination therapies. The Association’s Part The Cloud initiative has funded 60 distinct and innovative clinical trials.
This article is based on a press release from the Alzheimer’s Association.