Your GBA1 Enrollment Plan Is Built for European Sites — And That’s a Problem
Lancet Neurology data shows <4% of Parkinson's genetic trials enroll non-European patients. Here's what ops teams must fix before...
Parkinson’s Disease
The Genetics Are Global. Your Enrollment Plan Isn’t.
A landmark Lancet Neurology study exposes the operational gap in Parkinson's trials: ancestry-based biomarker screening built for European cohorts...
The Genetic Trial Diversity Problem Is Now a Site Operations Problem
A 99,783-person multi-ancestry Parkinson's study just exposed a critical enrollment gap: GBA1 and LRRK2 trials run almost exclusively in...
GCP Breakdown at King’s College Hospital Just Clouded the Most Promising Parkinson’s Trial in Years
An MHRA inspection at King's College Hospital flagged department-wide GCP failures in the exenatide Phase 3 Parkinson's trial, triggering...
Adaptive DBS Just Rewrote the Rules for CNS Trial Design — Is the FDA Ready?
A Nature Medicine randomized trial shows adaptive DBS cuts gait variability in Parkinson's. The real story is what its...
Closed-Loop DBS Just Validated a New Class of CNS Trial Design. Is Your Protocol Ready?
A UCSF randomized trial of adaptive DBS in Parkinson's gait published in Nature Medicine signals a coming wave of...
Adaptive DBS Just Ran a Randomized Trial on Gait. The Endpoints FDA Needs to Validate Next Are Nowhere in Current Guidance.
A Nature Medicine feasibility trial on adaptive deep brain stimulation for Parkinson's gait signals a regulatory gap: FDA has...
Gene Therapy Just Delivered Dopamine Directly Into the Brain. Now Comes the Hard Part.
BBM-P002's Phase 1 data in 10 Parkinson's patients shows dual-target AAV gene therapy can restore dopamine synthesis. The FDA...
CNS Gene Therapy Trials Are About to Break Every Monitoring Assumption Your CRO Has
BBM-P002's multicenter Phase 1 Parkinson's data signals a wave of CNS gene therapy trials that will overwhelm standard eClinical...
The $30 Million Bet: CNS Investors Are Back — and Registrational Trial Design Hasn’t Kept Up
Serina Therapeutics just closed a $30 million private placement at a 68% premium to fund a registrational trial for...