NCT06745583

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an open-label, phase II, exploratory, proof-of-concept study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or sever Alzheimer's disease (AD). The main goals include: 1. to validate mechanism-engagement of EI-1071 by tracing the change of activated microglia in selected brain regions in AD patients using TSPO PET/MRI imaging. 2. to assess effects of EI-1071 on changes of inflammatory biomarkers associated with AD progression.

Conditions

• Mild, Moderate, or Severe Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	EI-1071 tablet, oral	Dose: 448.2 mg BID for 28 days

Timeline

• Start date: 2024-12-16
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-12-20
• Last updated: 2026-04-09

Locations

2 sites across 1 country: Taiwan