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Alzheimer's DiseasePhase 2NCT06602258

A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease

A Phase 2 study testing E2814 and Lecanemab in people with Alzheimer's Disease, run by Eisai Inc. at 26 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD). Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
E2814 and Lecanemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
26 sitesin 2 countries
Study dates
30 Sep 2024to 18 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For participants diagnosed with mild cognitive impairment (MCI) due to AD-intermediate likelihood:
  • Meet the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to AD-intermediate likelihood
  • 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
  • For participants diagnosed with mild AD dementia:
  • Meet the NIA-AA core clinical criteria for probable AD dementia
  • Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of >=0.5 at Screening
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  • Mini Mental State Examination (MMSE) score >=22 at Screening and less than or equal to (<=) 30 at Screening
  • 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
  • Male or female participants aged between >=50 years and <=80 years, at the time of informed consent
  • 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
  • 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).
  • 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)
  • Willing and able to comply with all aspects of the protocol including multiple CSF collections

Who cannot join

  • Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
  • History of transient ischemic attacks, stroke, or seizures within 12 months of Screening
  • 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
  • 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
  • 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
  • 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])
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  • 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
  • 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
  • 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
  • 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)
  • 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
  • Hypersensitivity to lecanemab, E2814, or any of the excipients
  • 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
  • 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
  • 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
  • Known to be human immunodeficiency virus positive
  • 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
  • Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately
  • Participation in a clinical study involving any antiamyloid plaque lowering or anti-tau therapies (including any mAb and antisense oligonucleotide therapies unless it can be documented that the subject only received placebo)
  • Participation in a clinical study involving any therapeutic mAb, protein derived from a mAb, immunoglobulin therapy, or vaccine within 6 months before Screening unless it can be documented that the subject only received placebo

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States18 sites

  • Abington Neurological Associates LTD

    Abington, Pennsylvania, 19001

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • K2 Medical Research

    Clermont, Florida, 34711

  • Columbus Memory Center, PC

    Columbus, Georgia, 31909

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • Kerwin Memory Center

    Dallas, Texas, 75231

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Advanced Clinical Research Network

    Miami, Florida, 33165

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Banner Sun Health Research

    Phoenix, Arizona, 85006

  • Progressive Medical Research

    Port Orange, Florida, 32124

  • National Clinical Research-Richmond, Inc

    Richmond, Virginia, 23294

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Alzheimer's Research and Treatment Center-Stuart

    Stuart, Florida, 34997

  • Axiom Brain Health

    Tampa, Florida, 33609

  • Charter Research

    The Villages, Florida, 32162

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33467

Other trials in United States

Japan8 sites

  • Keimei Memorial Hospital

    Honjō, Miyazaki, 880-1111

  • Rijikai Medical Corporation Katayama Medical Clinic

    Kurashiki, Okayama-ken, 710-0813

  • National Center for Geriatrics and Gerontology

    Ōbu, Aichi-ken, 474-8511

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Ōtake, Hiroshima, 739-0696

  • Tokyo Medical University Hospital

    Shinjuku, Tokyo, 160-0023

  • Keio University Hospital

    Shinjuku, Tokyo, 160-8582

  • Yamagata Tokushukai Hospital

    Yamagata, 990-0834

Other trials in Japan

About this study

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

The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD).

Being tested
E2814, Lecanemab, Placebo
Keywords
Early Alzheimer's Disease, E2814, Lecanemab
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2814Drug

    E2814 IV infusion.

  • LecanemabDrug

    Also called BAN2401, LEQEMBI

    Lecanemab SC injection.

  • PlaceboDrug

    Placebo IV infusion.

Study groups in NCT06602258
Study groupRoleWhat they receive
E2814 Dose A + LecanemabExperimentalParticipants will receive E2814 Dose A administered as an intravenous (IV) infusion, every four weeks (Q4W) along with lecanemab administered as a subcutaneous (SC) injection, every week (QW).
Receives: Drug: E2814; Drug: Lecanemab
E2814 Dose B + LecanemabExperimentalParticipants will receive E2814 Dose B administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.
Receives: Drug: E2814; Drug: Lecanemab
E2814 Dose C + LecanemabExperimentalParticipants will receive E2814 Dose C administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.
Receives: Drug: E2814; Drug: Lecanemab
E2814 Dose D + LecanemabExperimentalParticipants will receive E2814 Dose D administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.
Receives: Drug: E2814; Drug: Lecanemab
Placebo + LecanemabExperimentalParticipants will receive placebo administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.
Receives: Drug: Lecanemab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in CSF MTBR-tau-243 at 6 Months

    Measured: Baseline at 6 months

Secondary outcomes (10)

  1. Change From Baseline in Tau Positron Emission Tomography (PET) up to 24 Months

    Measured: Baseline up to 24 months

  2. Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) up to 24 Months

    Measured: Baseline up to 24 months

  3. Change From Baseline in Alzheimers Disease Cooperative Scale-Activities of Daily Living Mild Cognitive Impairment Version (ADCS MCI-ADL) up to 24 Months

    Measured: Baseline up to 24 months

  4. Serum Anti-E2814 Antibody (ADA) Concentration

    Measured: Baseline up to 27 months

  5. AUC: Area Under the Serum Concentration Versus Time Curve of E2814

    Measured: Baseline up to 27 months

  6. Cav: Average Serum Concentration of E2814

    Measured: Baseline up to 27 months

  7. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: From first dose of the study drug up to 27 months

  8. Number of Participants With Markedly Abnormal Laboratory Parameters

    Measured: From first dose of the study drug up to 27 months

  9. Number of Participants With Clinically Significant Vital Signs Values

    Measured: From first dose of the study drug up to 27 months

  10. Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

    Measured: From first dose of the study drug up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start30 Sep 2024
  3. Primary completion3 Dec 2026 (estimated)
  4. Study completion18 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602258
Sponsor's protocol ID
E2814-G000-202
Status last verified
Jan 2026
First submitted
16 Sep 2024
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E2814 and Lecanemab in people with Alzheimer's Disease, run by Eisai Inc. at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in CSF MTBR-tau-243 at 6 Months (time frame: Baseline at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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