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NCT04971733 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Alzheimer Disease, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 3
- Study locations
NCT04971733: Completed Phase 1 study of Alzheimer Disease, sponsored by Eisai.
NCT04971733 is a Phase 1 study of Alzheimer Disease that has completed, run by Eisai. The registered enrollment target is 8 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04971733, a Phase 1 study of Alzheimer Disease, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
A TEAE was defined as adverse event (AE) that started at or after the time of administration of study drug or a worsening of severity from Baseline on or after 1st dose up to last assessment. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product. SAE was any untoward medical occurrence that at any dose: resulted in death; was life-thr
Conditions Studied
Interventions
- DRUG E2814
Study Locations (3)
California
- UC San Diego Altman Clinical and Translational Research Insititute Clinic - La Jolla
Indiana
- Indiana University School of Medicine, Health Partners, Adult Neurology Clinic - Indianapolis
Other
- National Hospital for Neurology and Neurosurgery (NHNN) University College London(UCL) Hospitals NHS Foundation Trust - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2024-05-24 |
| Phase | Phase 1 |
What the finished NCT04971733 record still lists
NCT04971733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which E2814 is the first listed.
NCT04971733 reports a single indexed study location in California, Indiana, Other.
Frequently Asked Questions
What is clinical trial NCT04971733 about?
NCT04971733 is a clinical study titled "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". 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 f...
What is the current status of trial NCT04971733?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-06-28. Estimated completion is 2024-05-24.
What conditions does trial NCT04971733 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT04971733?
The interventions under investigation include: E2814 (DRUG).
Who is sponsoring clinical trial NCT04971733?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04971733 being conducted?
This trial has 3 study locations across California, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04971733's enrollment target sits among peer trials
8 296th of 306 higher than 8 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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