Eisai Clinical Trials
Study Overview
E2511
N/A
NCT07768592
Oct 2026 -
Alzheimer's disease
1. Part A (Core Trial): Change from Baseline in [11C]MK-6884 Positron Emission Tomography (PET) Using Non-Displaceable Binding Potential (BPND) at 14 Days [ Time Frame: Baseline up to Day 14 ]
2. Part A and B (Extension Phase): Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 91 weeks ]
3. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Vital Sign Values [ Time Frame: From Week 13 up to Week 91 ]
4. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values [ Time Frame: From Week 13 up to Week 91 ]
5. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Physical Exam [ Time Frame: From Week 13 up to Week 91 ]
6. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Neurological Exam [ Time Frame: From Week 13 up to Week 91 ]
7. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Laboratory Safety Tests Values [ Time Frame: From Week 13 up to Week 91 ]
8.Part A and B (Extension Phase): Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 91 weeks ]
2. Part A and B (Extension Phase): Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 91 weeks ]
3. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Vital Sign Values [ Time Frame: From Week 13 up to Week 91 ]
4. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values [ Time Frame: From Week 13 up to Week 91 ]
5. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Physical Exam [ Time Frame: From Week 13 up to Week 91 ]
6. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Neurological Exam [ Time Frame: From Week 13 up to Week 91 ]
7. Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Laboratory Safety Tests Values [ Time Frame: From Week 13 up to Week 91 ]
8.Part A and B (Extension Phase): Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 91 weeks ]
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Males and females aged 50 Years to 85 Years
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Ongoing -
Phase 1
CanadaData Sharing
ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.
CSDR Sharing is not available for this study.
CSDR Availability Clinical Trial Data Redacted documents may be available upon request for this study.
Document type Availability Protocol SAP Sample CRF Full CSR