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A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)

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NCT07768592 · 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
DateFiledBasisWhat it is
Start2026-10-15estimatedWhen the study began enrolling
Primary completion2030-05-06estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2030-05-06estimatedThe whole study's end, after follow-up
First posted2026-08-17actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-17actualThe 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 OF
Part 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

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