A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation i… (NCT06745583) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients
Taiwan15 participantsStarted 2024-12-16
Plain-language summary
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
Who can participate
Age range50 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Must meet all the clinical criteria for mild to severe AD (i.e., probable or possible AD dementia by NIA-AA criteria; must have objective evidence of cognitive impairment at Screening
✓. Clinical Dementia Rating Scale (CDR)≧0.5
✓. If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening.
✓. Adequate hematologic, hepatic, and renal function at the screening visit defined by the following criteria:
✓. Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit (female subjects must be surgically confirmed sterile, i.e., had hysterectomy, bilateral oophorectomy, or tubal ligation procedures), post-menopausal for at least 1 year (documented in the medical history), or must commit to use two contraceptive methods during the study.
✓. Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes:
✓. Male subject who agrees to use an adequate method of contraception during the study period \[e.g., barrier contraceptives (male condom)\].
✓. Subjects or his/her legal representative or guardian are willing to sign written informed consent and willing to comply with study requirements.
Exclusion criteria
✕. Body weight ≥ 150 kg or body mass index (BMI) ≥ 35 kg/m² at the screening visit.
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What they're measuring
1
Change from Baseline to Week 4 [¹⁸F] FEPPA Binding in Selected Brain Regions of Interest
. 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).
✕. AD patients with low binding affinity for tracer TSPO rs6971 SNP polymorphism at screening
✕. Pregnant, breast feeding or plan to be pregnant women during the study period
✕. Active tuberculosis (TB), active or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) or known active or chronic infection with human immunodeficiency virus (HIV) at screening or in the medical history.
✕. Any medical or neurological/neurodegenerative condition (including mental deficit, intracranial tumor, glioma or meningioma; head trauma, Lewy body dementia; other disease than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
✕. Clinically significant, unstable psychiatric illness or have contraindications to brain magnetic resonance imaging (MRI) or PET scans
✕. Have had a stroke or Transient Ischemic Attack (TIA), unexplained loss of consciousness or relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities in the past year based on medical history (with MRI imaging results as confirmation in the medical history) at screening. Subjects with clinically relevant cerebrovascular abnormalities in MRI will be excluded per PI's discretion.