Pre alzheimer's disease-urolithina (PADUA)
PADUA TRIAL — PARTNERSHIP BRIEF Preclinical Alzheimer's Disease Urolithin A Study Co-Investment Opportunity | Loma Linda University Alzheimer's Research Group | April 2026 Why This Trial Matters PADUA directly generates peer-reviewed, biomarker-validated clinical evidence for Urolithin A's effect on Alzheimer's pathology — in a rigorously designed, academically independent trial. STUDY DESIGN • Design: Randomized, double-blind, placebo-controlled • Population: 200 adults aged 60–90 with preclinical AD (pTau217 ≥ 0.30 pg/ml); no dementia diagnosis • Intervention: UA 1,000 mg/day oral capsules vs. matched placebo — 6 months • Recruitment: LLUH Family Medicine, Southern California — • Platform: pTau217 measured by MSD electrochemiluminescence — same assay used in landmark donanemab trials ENDPOINTS & BIOMARKERS • Primary: Change in plasma pTau217 at 6 months • Mitochondrial health: Mitophagy markers, oxidative stress, synaptic proteins, vascular disruption • Cognitive trajectory: Dementia SomaSignal Test — proteins predictive of future cognitive decline • Pharmacokinetics: Plasma UA levels confirming absorption and exposure
SCIENTIFIC RATIONALE Urolithin A is a gut microbiome-derived compound that crosses the blood-brain barrier and reduces mitochondrial dysfunction through mitophagy activation — a hallmark pathway in preclinical Alzheimer's Disease. The PADUA trial is powered to detect a meaningful change in pTau217, mirroring the biomarker-enriched design of the donanemab (Kisunla) program, which demonstrated significant pTau217 reduction within 6 months. UA's safety and pharmacokinetic profile is well-characterized in prior human studies. CO-INVESTMENT OPPORTUNITY $650,000 Co-investment sought $650,000 Philanthropic funds secured 200 subjects 6-month RCT Academic IP LLU retains all trial data
CONFIDENTIAL — For discussion purposes only. Full protocol available after CDA execution. | LLU Alzheimer's Research Group | April 2026
About Loma Linda University
Loma Linda University is a private, faith-based health sciences university serving the Inland Empire and Greater Los Angeles region. Integration with a major academic medical center and a children’s hospital enables rapid industry collaboration, from feasibility assessments and contracting to multi-site trials and real-world evidence studies, supported by experienced regulatory and data teams. Corporate partners benefit from access to specialty treatment environments, streamlined research administration, and recruitment across a large, diverse patient population. Research is supported by funding from the National Institutes of Health and other competitive federal sponsors. A dedicated technology transfer office manages IP protection, licensing, and startup formation.
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