Responding to an article written in AlzForum on the future of Alzheimer’s treatment and research from October 7th, Joshua Grill, PhD, from UCI MIND, and his colleague, Jason Karlawish, MD, from the University of Pennsylvania, write:
Josh Grill, Professor, Psychiatry & Human Behavior
photo: Steve Zylius/UCI
“Anticipation that FDA will grant full approval of lecanemab (or another disease-modifying treatment) invites an exciting but challenging thought exercise: How will such treatments change research and practice for Alzheimer’s disease (AD)?
We’ve considered some of the issues. Our top line point is that a new disease-slowing treatment is unlikely to make use of placebo controls immediately and categorically unethical (Grill and Karlawish, 2021). In this same paper, we anticipate the importance of factorial designs to the next phase of AD drug development. Such designs can enable efficient opportunities to test potential treatments against each other as well as for synergistic benefits (or risks), and still maintain the necessary rigor of comparison against placebo controls. These trials will likely enroll populations based on specific biomarker profiles—namely, each element of the ATN criteria—but also other biomarkers. In trials that enroll persons with MCI and dementia, protocols can better address not only the need to return these biomarker results to participants, but how best to do so.
The field also needs to consider what options are available to individuals interested in enrolling in trials who do not qualify to do so, especially in the setting of increasingly narrow eligibility criteria. Addressing these needs will be key to fostering trust in research and accelerating drug discovery that answers key clinical questions.”
