RecruitingPhase 2NCT06745583

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

An Open-label, Exploratory, Phase II, Proof-of Concept, Clinical Study to Assess the Safety and Tolerability of EI-1071 in Patients With Alzheimer's Disease (AD)


Sponsor

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Enrollment

15 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests an experimental drug called EI-1071 for people with mild to severe Alzheimer's disease. The drug targets neuroinflammation (inflammation in the brain), and researchers are evaluating its safety and whether it reduces brain inflammation as measured by PET scans. **You may be eligible if...** - You have a confirmed diagnosis of Alzheimer's disease (mild to severe) - You have measurable cognitive impairment - If you are already taking Alzheimer's medications, the dose has been stable for at least 8 weeks - Your blood counts, liver, and kidney function are adequate - You or your legal guardian can provide informed consent **You may NOT be eligible if...** - Your body weight is 150 kg or more, or your BMI is 35 or above - You have previously taken pexidartinib or other drugs targeting the same pathway within the past 3 months - You are pregnant, breastfeeding, or planning to become pregnant - You have active tuberculosis, HIV, or untreated hepatitis B or C - You have had a stroke or significant brain bleed in the past year - You have another significant neurological or psychiatric condition contributing to your cognitive decline - You are taking strong CYP3A4 inhibitors or inducers (certain medications that affect drug metabolism) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEI-1071 tablet, oral

Dose: 448.2 mg BID for 28 days


Locations(2)

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06745583