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The PIONEER Study: A multi‐center, randomized, double‐blind, placebo‐controlled phase 2 trial of the effects of T3D‐959 on safety, cognition, function and plasma biomarkers in mild to moderate Alzheimer’s disease subjects: Rationale and study design

Dysfunctional glucose and lipid metabolism are key drivers underlying pathological pathways ultimately resulting in Alzheimer’s disease (AD). T3D‐959 is a small molecule, orally delivered, brain penetrating, novel PPAR delta agonist with 15‐fold lower PPAR gamma potency that acts to maintain homeostasis of glucose and lipid metabolism. Ubiquitous brain expression of PPAR‐delta, its critical role in regulating glucose and lipid metabolism and phenotype of PPAR‐delta null mice, coupled with a promising safety profile and multiple efficacy signals in an exploratory Phase 2a clinical trial (NCT02560753) in patients with mild‐to‐moderate AD, provide the foundation for the next Phase 2 clinical trial, the PIONEER Study [Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration].