Phase II Clinical Trial to Evaluate the Safety and Feasibility of Senolytic Therapy in Alzheimer's Disease: "Senolytic Therapy to Modulate the Progression of Alzheimer's Disease (SToMP-AD)" Study

Amnestic mild cognitive impairment (aMCI, single or multi-domain) or early stage Alzheimer's Disease

Safety of 12 weeks of treatment with dasatinib and quercetin as compared to placebo, as measured by incidence of AEs and SAEs from baseline to week 48. Treatment with Dasatinib + Quercetin is expected to be as safe as placebo when comparing incidence of SAEs between groups. AEs and SAEs will be collected at each in-person visit and at scheduled telephone visits.

Change in blood senescence marker SASP composite score from baseline to week 12. Biomarker analysis will include a composite score generated from ten core SASP factors (i.e., IL-9, IL-1a, IL-6, IL-2, MMP-9, MMP-12, MMP-2, FGF-2, IL-1RA, and GM-CSF). Blood collections will be obtained at baseline, after 12 weeks treatment of D+Q (or placebo), and every 12 weeks during follow up visits under fasted conditions., Change in p16INK4a+/CD3+ T cells in blood from baseline to week 12. The biomarker analyses will include quantifying senescent cells in blood (p16INK4a+/CD3+ T cells). Blood collections will be obtained at baseline, after 12 weeks treatment of D+Q (or placebo), and every 12 weeks during follow up visits under fasted conditions., Change in CDR Sum of Boxes (CDR-SB) slope from screening to week 48. The CDR will be performed at screening, at week 12 of treatment and end of study at week 48., Change in ADAS-Cog slope from baseline to week 48.

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