Alsumidaie Urges FDA to Clear Path for 4,000-Per-Arm Dementia Vaccine Trials
Updated
Updated · clinicaltrialvanguard.com · Jun 19
Alsumidaie Urges FDA to Clear Path for 4,000-Per-Arm Dementia Vaccine Trials
1 articles · Updated · clinicaltrialvanguard.com · Jun 19
Summary
A 2026 appeal from Clinical Trial Vanguard editor Moe Alsumidaie asks the FDA to create a formal route for testing shingles vaccines as dementia-prevention tools, arguing regulatory ambiguity is blocking trials before they start.
More than 4,000 participants per arm could be needed for a three-year prevention study, he said, and sponsors lack FDA guidance on acceptable endpoints, evidence standards and how to pursue a supplemental biologics license application.
The push follows a Nature Medicine paper arguing large randomized trials are overdue, citing epidemiological links between varicella-zoster virus reactivation and higher dementia risk and suggesting live-attenuated Zostavax may be the key vaccine to test.
Alsumidaie asked CBER to hold a public workshop in 2026, issue draft guidance for Type B meeting requests and spell out safety rules for live-attenuated vaccines, which are contraindicated in some immunocompromised older adults.
The stakes are broad: Alzheimer’s affects an estimated 6.9 million Americans age 65 and older, and he argued that without agency clarity, potentially preventive evidence could be delayed by a decade.