Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01230853 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01230853: Completed Phase 1 study, sponsored by Eisai.
NCT01230853 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230853, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The purpose of this study will be to evaluate the safety and tolerability of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).
Primary Outcome
To evaluate the safety and tolerability of single intravenous (i.v.) infusions of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD)
Interventions
- DRUG Active Comparator: A
- DRUG Placebo Comparator B
- DRUG Active Comparator B
- DRUG Placebo Comparator A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT01230853 record still lists
NCT01230853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 4 interventions - of which Active Comparator: A is the first listed.
NCT01230853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01230853 about?
NCT01230853 is a clinical study titled "A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study". The purpose of this study will be to evaluate the safety and tolerability of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).
What is the current status of trial NCT01230853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2010-08. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01230853?
The interventions under investigation include: Active Comparator: A (DRUG), Placebo Comparator B (DRUG), Active Comparator B (DRUG), Placebo Comparator A (DRUG).
Who is sponsoring clinical trial NCT01230853?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01230853's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia