OncoMatch/Clinical Trials/NCT06745583
A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients
Is NCT06745583 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies EI-1071 tablet, oral for mild, moderate, or severe alzheimer's disease.
Treatment: EI-1071 tablet, oral — An open-label, exploratory, phase II, proof-of concept, clinical study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or severe Alzheimer's disease
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Excluded: TSPO rs6971 SNP low binding affinity
AD patients with low binding affinity for tracer TSPO rs6971 SNP polymorphism at screening
Prior therapy
Cannot have received: CSF-1 or CSF-1 receptor inhibitor (pexidartinib)
Exception: previous uses of oral tyrosine kinase inhibitors are allowed (e.g., imatinib or nilotinib)
Prior use of pexidartinib (Turalio), other chemical entities, or any biologic treatment targeting colony stimulating factor 1 (CSF-1) or the CSF-1 receptor within 3-month of the first dose with EI-1071; previous uses of oral tyrosine kinase inhibitors are allowed (e.g., imatinib or nilotinib).
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Hemoglobin > 10 g/dL; Platelet count ≥ 100 × 10⁹/L
Kidney function
Creatinine clearance (CCr) ≥ 60 mL/min
Liver function
AST and ALT ≤ 1 × ULN; total and direct bilirubin ≤ 1.0 × ULN; ALP ≤ 1.0 × ULN
Adequate hematologic, hepatic, and renal function at the screening visit defined by the following criteria: * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L * Hemoglobin [Hgb] > 10 g/dL * Platelet count ≥ 100 × 10⁹/L * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1 × upper limit of normal (ULN) * Total bilirubin and direct bilirubin ≤ 1.0 × ULN * Alkaline phosphatase (ALP) ≤ 1.0 × ULN * Creatinine clearance (CCr) ≥ 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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