Trial design & recruitment
Biomarker-enriched trials, prodromal cohorts and patient-recruitment networks.
State of the art
No update yet for Trial design & recruitment. An update is a standalone state-of-the-art for the topic — what someone with Parkinson's needs to know about where this approach stands today.
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Co‐ and Multi‐Pathologies in Parkinson's Disease: An International Parkinson and Movement Disorder Society Scientific Issues Committee Review
The review explicitly argues that uncharacterised co-pathology burden is a major but largely unaddressed source of heterogeneity in PD trial populations — a patient's response to an alpha-synuclein-targeting therapy could be masked or confounded by concurrent Alzheimer or vascular pathology — and calls for routine multi-pathology biomarker screening as part of standard PD trial design. -
PD GENEration: An International Parkinson's Disease Genetic Research Study
PD GENEration is explicitly designed as a recruitment pipeline for genetics-targeted precision-medicine trials: participants found to carry GBA1 or LRRK2 variants are informed of eligible trials, and the 20,000+ participant registry with whole-genome sequencing is being made publicly available through GP2 to accelerate trial design. The transition to WGS also enables identification of a 21-gene expanded PD panel alongside secondary findings (BRCA1/2, Lynch syndrome, familial hypercholesterolemia genes), broadening the return-of-results model used in trial recruitment. -
Cellular Intelligence acquires global rights to STEM-PD program
The STEM-PD Phase 1/2 trial targets adults aged 50–75 with moderate Parkinson's of more than 10 years' duration whose symptoms are not well controlled by oral therapies; eight participants have been enrolled at two sites (UK and Sweden), and the FDA has now cleared advancement into Phase 2 development. -
Phase 3 trial of solengepras for Parkinson’s disease now fully enrolled
The Phase 3 ARISE trial (NCT06553027) testing solengepras has completed enrollment of 341 participants with motor fluctuations (≥3 hours daily off time) across 94 sites internationally, with topline data expected in Q3 2026. -
Multi-locus genetic dosage shapes cognitive disease progression in Parkinson’s patients: 15-year meta-analysis of 24 cohorts
The authors highlight that a multi-locus genetic dosage score could sharpen trial recruitment by enrolling patients most likely to experience cognitive endpoints within a trial window. The 7.49-fold risk difference between zero and three-or-more variants suggests that genetically stratified enrolment could substantially reduce the sample sizes needed to detect a cognitive benefit in dementia-prevention studies. -
Daily‐Life, Sensor‐Derived Tremor Measures Are Sensitive to Progression in Early Parkinson's Disease
Because the sensor-derived tremor measures are far more sensitive to change than annual clinical ratings, adopting them as outcome measures in early-PD trials could meaningfully reduce the sample size or follow-up time needed to detect whether a disease-modifying treatment is working — a practical advance for trial design.