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Tests treatment safety and results for Mild, Moderate, or Severe Alzheimer's Disease
Official title A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients
ClinicalTrials.gov ID: NCT06745583
What this study is testing
What is EI-1071 tablet, oral?
EI-1071 tablet, oral is an investigational medicine, being studied as a potential treatment for mild, moderate, or severe alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- 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...
- 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:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
You likely can't join if
- Body weight ≥ 150 kg or body mass index (BMI) ≥ 35 kg/m² at the screening visit.
- Prior use of pexidartinib (Turalio), other chemical entities, or any biologic treatment targeting colony stimulating factor 1 (CSF-1) or the CSF-1...
- 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...
- Any medical or neurological/neurodegenerative condition (including mental deficit, intracranial tumor, glioma or meningioma; head trauma, Lewy body...
See the full eligibility 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:
- 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
- Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit (female people must be surgically confirmed sterile, i.e., had hysterectomy, bilateral oophorectomy, or tubal...
- Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes:
- Intrauterine device plus one barrier method
- Oral, implantable, or injectable contraceptives plus one barrier method; or
- Two barrier methods
- Effective barrier methods are male or female condoms, diaphragms, or spermicides (creams or gels that contain a chemical to kill sperm). Women of childbearing potential are those who have not been surgically sterilized...
- Male subject who agrees to use an adequate method of contraception during the study period [e.g., barrier contraceptives (male condom)].
- people or his/her legal representative or guardian are willing to sign written informed consent and willing to comply with study requirements.
- Body weight ≥ 150 kg or body mass index (BMI) ≥ 35 kg/m² at the screening visit.
- 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...
- 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...
- 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...
- 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...
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine (including poor-controlled T2DM), neurological, immunodeficiency, pulmonary, or other disorder or...
- History of or ongoing malignancy or carcinoma (either concurrent or within the last year of starting study treatment) that requires therapy (e.g., surgical, chemotherapy, or radiation therapy), except for adequately...
- Currently participating in any other clinical study or have participated in clinical trial within the last 60 days prior to screening; had donated blood (≥ 250 mL) within 30 days at screening.
- Known allergy to EI-1071 or hypersensitivity to any component of the formulation (e.g., hydroxypropyl methylcellulose acetate succinate) or hypersensitivity to any radiochemical tracer or [¹⁸F]FEPPA radiochemical tracer
- Required to use strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and is anticipated to use these inhibitors or inducers during the study period
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.