NCT04971733

A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease

An Open-Label Phase 1b/2 Study to Assess Safety and Target Engagement of E2814 in Subjects With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the safety and tolerability of intravenous (IV) infusions of E2814 in participants with dominantly inherited Alzheimer's disease (DIAD), and to evaluate target engagement (TE) of E2814 on microtubule binding region (MTBR)-tau species in cerebrospinal fluid (CSF) in participants with DIAD.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	E2814	E2814 intravenous infusion.

Timeline

• Start date: 2021-06-28
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2021-07-21
• Last updated: 2025-06-10
• Results posted: 2025-06-10

Locations

3 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study