E2814 and Lecanemab treatment for early Alzheimer's disease
Official title: A Phase 2, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Study to Evaluate Safety, Tolerability, and Biomarker Efficacy of E2814 With Concurrent Lecanemab Treatment in Subjects With Early Alzheimer's Disease
Run by Eisai Inc. · NCT06602258 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a new treatment combining E2814 and lecanemab can help people with early Alzheimer's disease by looking at changes in their brain fluid and memory over 18 months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Eisai Inc. Industry-sponsored |
| Drugs / interventions | lecanemab |
| Locations | 35 sites (Sun City, Arizona and 34 other locations) |
| Trial ID | NCT06602258 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50 to 80 with mild cognitive impairment or mild Alzheimer's dementia who meet specific clinical criteria.
✕Probably not a fit
Patients with advanced Alzheimer's disease or those unable to undergo a lumbar puncture may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the dose response of E2814 when given alongside lecanemab in participants with early Alzheimer's disease. It focuses on measuring changes in cerebrospinal fluid tau levels over an 18-month period. Participants will be monitored for their cognitive function and overall health as part of the assessment. The study includes both a treatment group receiving E2814 and lecanemab and a placebo group for comparison.
Why it matters
Potential benefit: If successful, this treatment could slow the progression of early Alzheimer's disease and improve cognitive function in patients.
How similar studies have gone: Other studies have shown promise with similar approaches in targeting tau pathology in Alzheimer's disease, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. For participants diagnosed with mild cognitive impairment (MCI) due to AD-intermediate likelihood: 1. Meet the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to AD-intermediate likelihood 2. Have a global Clinical Dementia Rating Scale (CDR) score of 0.5 and a CDR Memory Box score of greater than or equal to (\>=) 0.5 at Screening 2. For participants diagnosed with mild AD dementia: 1. Meet the NIA-AA core clinical criteria for probable AD dementia 2. Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of \>=0.5 at Screening 3. Mini Mental State Examination (MMSE) score \>=22 at Screening and less than or equal to (\<=) 30 at Screening 4. Able to have CSF lumbar puncture performed and not on, or have a medical condition that may require initiation of, any anticoagulant therapy at Screening 5. Male or female participants aged between \>=50 years and \<=80 years, at the time of informed consent 6. If receiving an approved AD symptomatic treatment (such as acetylcholinesterase inhibitors (AchEIs), memantine, or both) for AD, participants must be on a stable dose for at least 12 weeks before Baseline. Treatment-naïve participants for AD medications can be enrolled into the study. Unless otherwise stated, participants must have been on stable doses of all other (that is, non AD-related) permitted concomitant medications for at least 4 weeks before Baseline. Use of memantine will not be allowed at screening for participants in Japan 7. Have an identified study partner (defined as a person able to support the participant for the duration of the study and who spends at least 8 hours per week with the participant). 8. Provide written informed consent. If a participant lacks the capacity to consent in the Investigator's opinion, the participants' assent should be obtained, if required in accordance with local laws, regulations, and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations) 9. Willing and able to comply with all aspects of the protocol including multiple CSF collections Exclusion Criteria: 1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD 2. History of transient ischemic attacks, stroke, or seizures within 12 months of Screening 3. Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participants. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening 4. Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in skull and cardiac devices other than those approved as safe for use in MRI scanners). Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD. Other significant pathological findings on brain MRI at Screening, including but not limited to: greater than 4 microhemorrhages (defined as 10 millimeter (mm) or less at the greatest diameter); a single intracerebral hemorrhage greater than 10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary). Other minor or clinically insignificant magnetic resonance imaging (MRI) abnormalities, as agreed by the medical monitor and after discussion with the investigator, may not be exclusionary 5. Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male participants, or localized breast cancer in female participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded 6. A clinically significant ECG abnormality, including a marked prolonged corrected QT interval (Fridericia's Correction Formula; QTcF) interval (example, a repeated demonstration of a QTcF interval greater than (\>) 450 milliseconds \[ms\]) 7. Participants with a bleeding disorder that is not under adequate control (including a platelet count \<50,000 or international normalized ratio \[INR\] \>1.5). Any participants who are on anticoagulant therapy are not permitted to be enrolled 8. Have thyroid-stimulating hormone above normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all participants whether or not they are taking thyroid supplements 9. Abnormally low serum vitamin B12 levels for the testing laboratory (if participant is taking vitamin B12 injections, level should be at or above the lower limit of normal for the testing laboratory). Levels of vitamin B12 may be confirmed with reflex testing to include methylmalonic acid analysis, if available in region 10. Any suicidal ideation with intent with or without a plan at Screening, Baseline, or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening) 11. Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, and renal disease) that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessments. Any other medical conditions (example, cardiac, respiratory, gastrointestinal, and renal disease) that are not stably and adequately controlled or that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments 12. Hypersensitivity to lecanemab, E2814, or any of the excipients 13. Any immunological disease, that is not adequately controlled, or that requires treatment with immunoglobulins, systemic monoclonal antibodies (mAbs) (or derivatives of mAbs), systemic immunosuppressants, or plasmapheresis during the study 14. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study 15. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery that requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety 16. Known to be human immunodeficiency virus positive 17. Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening. Participants who test positive for benzodiazepines or opioids in urine drug testing need not be excluded if in the clinical opinion of the investigator, this is due to the participant taking prior/concomitant medications containing benzodiazepines or opioids for a medical condition and not due to drug abuse 18. Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately
Where it's running
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Bradenton Research Center
Bradenton, Florida, United States Recruiting -
K2 Medical Research
Clermont, Florida, United States Recruiting -
Charter Research
Lady Lake, Florida, United States Recruiting -
Advanced Clinical Research Network
Miami, Florida, United States Recruiting -
Renstar Medical Research
Ocala, Florida, United States Recruiting -
Progressive Medical Research
Port Orange, Florida, United States Recruiting
Show 29 more locations
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Alzheimer's Research and Treatment Center
Stuart, Florida, United States Recruiting -
ClinCloud Research, LLC
Viera, Florida, United States Recruiting -
Alzheimer's Research and Treatment Center
Wellington, Florida, United States Recruiting -
Washington University School of Medicine
Saint Louis, Missouri, United States Recruiting -
Abington Neurological Associates Ltd
Abington, Pennsylvania, United States Recruiting -
Keystone Clinical Research LLC
Plymouth Meeting, Pennsylvania, United States Recruiting -
Neurology Clinical, P.C.
Cordova, Tennessee, United States Recruiting -
Kerwin Medical Center
Dallas, Texas, United States Recruiting -
National Clinical Research-Richmond, Inc
Richmond, Virginia, United States Recruiting -
National Center for Geriatrics and Gerontology
Obu, Aichi, Japan Recruiting -
National Hospital Organization Hiroshima-Nishi Medical Center
Otake, Hiroshima, Japan Recruiting -
Keimei Memorial Hospital
Higashimorokatagun, Miyazaki, Japan Recruiting -
Rijikai Medical Corporation Katayama Medical Clinic
Kurashiki, Okayama, Japan Recruiting -
Nippon Medical School Hospital
Kanagawa, Japan Recruiting -
Yamagata Tokushukai Hospital
Yamagata, Japan Recruiting -
Banner Sun Health Research Institute
Sun City, Arizona, United States Not yet recruiting -
Sharp Neurocognitive Research Center at Sharp Mesa Vista Hospital
San Diego, California, United States Not yet recruiting -
University of California at San Francisco/UCSF
San Francisco, California, United States Not yet recruiting -
Yale University School of Medicine
New Haven, Connecticut, United States Not yet recruiting -
Axiom Brain Health
Tampa, Florida, United States Not yet recruiting -
Columbus Memory Center, PC
Columbus, Georgia, United States Not yet recruiting -
Memory Center/Hattiesburg Clinic
Hattiesburg, Mississippi, United States Not yet recruiting -
Advanced Memory Research Institute
Toms River, New Jersey, United States Not yet recruiting -
AMC Research LLC, Formerly Alzheimer's Memory Center
Matthews, North Carolina, United States Not yet recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Withdrawn -
Osaka Metropolitan University Hospital
Osaka, Japan Not yet recruiting -
Tokyo Medical University Hospital
Tokyo, Japan Not yet recruiting -
Keio University Hospital
Tokyo, Japan Not yet recruiting -
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Tokyo, Japan Not yet recruiting
Study contacts
- Study coordinator: Eisai Medical Information
- Email: esi_medinfo@eisai.com
- Phone: +1-888-274-2378
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.