A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients

NCT06745583 | Recruiting Phase 2

• 2 other identifiers: EI-1071-202PTC-22-973334
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Mild, Moderate, or Severe Alzheimer's Disease

Keywords

Alzheimer's Disease; Neuroinflammation; Neurodegenerative Disorder; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 4 [¹⁸F] FEPPA Binding in Selected Brain Regions of Interest

  Change from baseline in volume of distribution (Vt) of \[¹⁸F\]FEPPA binding in selected brain regions of interest in each \[¹⁸F\]FEPPA Positron Emission Tomography (PET) scan obtained from individual patient after 28 days of EI-1071 repeated dosing

  Baseline, Week 4

Secondary Outcomes (15)

• Number of Participants With at Least One Adverse Events (AEs) or Serious Adverse Events (SAEs) by CTCAE v5.0

  From Day 1 up to Day 84

• Change From Baseline to Week 12 as Measured by CDR-SB

  Baseline, Week 4, Week 12

• Mean Change From Baseline to Week 12 in Mini Mental State Exam (MMSE) Score

  Baseline, Week 4, Week 12

• Change From Baseline to Week 12 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score

  Baseline, Week 4, Week 12

• Change From Baseline to Week 12 in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score

  Baseline, Week 4, Week 12

Study Arms (1)

EI-1071 dose

EXPERIMENTAL

Drug: EI-1071 tablet, oral

Interventions

EI-1071 tablet, oral DRUG

Dose: 448.2 mg BID for 28 days

EI-1071 dose

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 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:
• Intrauterine device plus one barrier method
• Oral, implantable, or injectable contraceptives plus one barrier method; or

You may not qualify 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 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.
• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine (including poor-controlled T2DM), neurological, immunodeficiency, pulmonary, or other disorder or disease at the screening visit (such as neurological or cognitive impairment/decline due to substance abuse, vitamin B12 deficiency, abnormal thyroid function, or other underlying condition might contribute to cognitive, functional or behavioral impairment will be excluded) by investigator's judgment at screening; subjects who have to be fed by enteral tube will be excluded.
• 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 treated basal or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix or breast
• 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

Sponsors & Collaborators

• Elixiron Immunotherapeutics (Hong Kong) Ltd.: lead

Study Sites (2)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 11490, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Alzheimer Disease; Neuroinflammatory Diseases; Neurodegenerative Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Central Study Contacts

Director Project Manager, Clinical Development

CONTACT

+886-2 2782 7700; chi-yun.pai@elixiron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)