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 (Jun 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
Treatments studied
Other
Biomarker criteria
Excluded: TSPO rs6971 SNP low binding affinity
AD patients with low binding affinity for tracer TSPO rs6971 SNP polymorphism at screening
Demographics
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.
Frequently asked questions
Is NCT06745583 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CSF-1 or CSF-1 receptor inhibitor disqualifies patients from enrollment.
Are patients with TSPO alterations eligible?
No. TSPO rs6971 SNP low binding affinity is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 85 years or younger and at least 50 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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