A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)
← catalyst calendarNCT07768592 · readout in 1,355 d
Sponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →.
Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
32estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-10-15 | estimated | When the study began enrolling |
| Primary completion | 2030-05-06 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-05-06 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Alzheimers Disease
Interventions
- Drug: E2511
- Drug: Donepezil — also filed as Aricept
Primary outcomes
what the primary-completion date above is the date OFPart A (Core Trial): Change from Baseline in [11C]MK-6884 Positron Emission Tomography (PET) Using Non-Displaceable Binding Potential (BPND) at 14 Days
measured Baseline up to Day 14
Part A and B (Extension Phase): Number of Participants With Adverse Events (AEs)
measured Up to 91 weeks
Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Vital Sign Values
measured From Week 13 up to Week 91
Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
measured From Week 13 up to Week 91
Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Physical Exam
measured From Week 13 up to Week 91
Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Neurological Exam
measured From Week 13 up to Week 91
Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Laboratory Safety Tests Values
measured From Week 13 up to Week 91
Part A and B (Extension Phase): Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
measured Up to 91 weeks
Permalink · 4523.T's whole pipeline · Catalyst calendar · Every registered study · What changed