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E2511 / Alzheimers Disease / Donepezil · Phase 1 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1 trial registration evaluating the investigational drug E2511 against donepezil in early Alzheimer's disease. The study aims to assess safety, tolerability, and proof of mechanism via PET imaging, with an optional 18-month extension phase. No results have been reported in this registry record.
Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Alzheimers Disease; age from 50 Years; to 85 Years. Intervention: Part A: E2511 Dose A; Part A: Donepezil Dose A; Part B: E2511 Dose B. Compared with: Donepezil (in Part A only); Part B is non-comparative.. n = 32.
This is a planned Phase 1 trial registration evaluating the investigational drug E2511 against donepezil in early Alzheimer's disease. The study aims to assess safety, tolerability, and proof of mechanism via PET imaging, with an optional 18-month extension phase. No results have been reported in this registry record.
This is a trial registration with no results posted; outcomes, effect sizes, and safety data are not yet reported.
The source did not state who this applies to in practice.
This is a Phase 1 trial registration with no reported results; it is designed to evaluate safety, tolerability, and proof of mechanism in a small population, and cannot yet inform clinical practice.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07768592). This is a study registration, not published results. Lead sponsor: Eisai Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 32 participants (ESTIMATED). Conditions: Alzheimers Disease. Interventions: DRUG: E2511; DRUG: Donepezil. Primary outcome measures: Part A (Core Trial): Change from Baseline in [11C]MK-6884 Positron Emission Tomography (PET) Using Non-Displaceable Binding Potential (BPND) at 14 Days , Baseline up to Day 14; Part A and B (Extension Phase): Number of Participants With Adverse Events (AEs) , Up to 91 weeks; Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Vital Sign Values , From Week 13 up to Week 91; Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values , From Week 13 up to Week 91; Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Physical Exam , From Week 13 up to Week 91; Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Neurological Exam , 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 , 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) , Up to 91 weeks. Brief summary: The primary purpose of this study is to evaluate proof of mechanism (POM) and long-term safety and tolerability of E2511 in participants with Early AD. The study consists of 2 parts. In Part A, participants will be randomly assigned to receive either E2511 or donepezil. In Part B, participants will receive E2511 only. Once Part A and Part B participants complete the Core Trial (which includes Pretreatment and Treatment phases) they will have the option to enter the Extension Phase where they will receive E2511 for 18 months.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.