Actively Recruiting
A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients
Led by Elixiron Immunotherapeutics (Hong Kong) Ltd. · Updated on 2026-04-09
15
Participants Needed
2
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must meet clinical criteria for mild to severe Alzheimer's disease with objective cognitive impairment
- Clinical Dementia Rating Scale (CDR) score of 0.5 or higher
- Stable doses of Alzheimer's symptom treatments for at least 8 weeks prior to screening
- Adequate blood and organ function at screening (specific blood counts and liver/kidney tests)
- Female participants must have negative pregnancy test or be surgically sterile, post-menopausal for at least 1 year, or use effective contraception
- Female participants of childbearing potential must commit to effective contraceptive methods during the study
- Male participants must agree to use contraception during the study
- Participants or their legal representatives must provide informed consent and agree to comply with study requirements
You will not qualify if you...
- Body weight 150 kg or higher or body mass index 35 kg/m2 or higher
- Use of pexidartinib or related treatments targeting CSF-1 or its receptor within 3 months before study start
- Low binding affinity for TSPO tracer at screening
- Pregnancy, breastfeeding, or plans to become pregnant during the study
- Active tuberculosis, hepatitis B or C, or HIV infection
- Other medical or neurological conditions that could affect cognition or study participation
- Unstable psychiatric illness or contraindications to brain MRI or PET scans
- Stroke, transient ischemic attack, brain hemorrhage, bleeding disorders, or cerebrovascular abnormalities in the past year
- Significant gastrointestinal, cardiovascular, liver, kidney, blood, cancer, endocrine, neurological, immunodeficiency, lung, or other disorders judged by investigator
- History of recent malignancy requiring therapy except certain skin or cervical/breast cancers
- Participation in other clinical trials within 60 days or blood donation of 250 mL or more within 30 days
- Allergies to EI-1071 or components of its formulation or to the radiochemical tracer used
- Use or anticipated use of strong inhibitors or inducers of CYP3A4 during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
2
Tri-Service General Hospital
Taipei, Taiwan, 11490
Actively Recruiting
Research Team
D
Director Project Manager, Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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