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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2814 Dose A + Lecanemab | Experimental | Participants 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). |
|
| E2814 Dose B + Lecanemab | Experimental | Participants will receive E2814 Dose B administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW. |
|
| E2814 Dose C + Lecanemab | Experimental | Participants will receive E2814 Dose C administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW. |
|
| E2814 Dose D + Lecanemab | Experimental | Participants will receive E2814 Dose D administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW. |
|
| Placebo + Lecanemab | Experimental | Participants will receive placebo administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2814 | Drug | E2814 IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CSF MTBR-tau-243 at 6 Months | Baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tau Positron Emission Tomography (PET) up to 24 Months | Baseline up to 24 months | |
| Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) up to 24 Months | Baseline up to 24 months |
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Inclusion Criteria:
For participants diagnosed with mild cognitive impairment (MCI) due to AD-intermediate likelihood:
For participants diagnosed with mild AD dementia:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research | Phoenix | Arizona | 85006 | United States | ||
| Yale University School of Medicine |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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|
| Lecanemab | Drug | Lecanemab SC injection. |
|
|
| Placebo | Drug | Placebo IV infusion. |
|
| Change From Baseline in Alzheimers Disease Cooperative Scale-Activities of Daily Living Mild Cognitive Impairment Version (ADCS MCI-ADL) up to 24 Months | Baseline up to 24 months |
| Serum Anti-E2814 Antibody (ADA) Concentration | Baseline up to 27 months |
| AUC: Area Under the Serum Concentration Versus Time Curve of E2814 | Baseline up to 27 months |
| Cav: Average Serum Concentration of E2814 | Baseline up to 27 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of the study drug up to 27 months |
| Number of Participants With Markedly Abnormal Laboratory Parameters | From first dose of the study drug up to 27 months |
| Number of Participants With Clinically Significant Vital Signs Values | From first dose of the study drug up to 27 months |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | From first dose of the study drug up to 27 months |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Bradenton Research Center | Bradenton | Florida | 34205 | United States |
| K2 Medical Research | Clermont | Florida | 34711 | United States |
| Advanced Clinical Research Network | Miami | Florida | 33165 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Progressive Medical Research | Port Orange | Florida | 32124 | United States |
| Alzheimer's Research and Treatment Center-Stuart | Stuart | Florida | 34997 | United States |
| Axiom Brain Health | Tampa | Florida | 33609 | United States |
| Charter Research | The Villages | Florida | 32162 | United States |
| Alzheimer's Research and Treatment Center | Wellington | Florida | 33467 | United States |
| Columbus Memory Center, PC | Columbus | Georgia | 31909 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Abington Neurological Associates LTD | Abington | Pennsylvania | 19001 | United States |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | United States |
| Kerwin Memory Center | Dallas | Texas | 75231 | United States |
| National Clinical Research-Richmond, Inc | Richmond | Virginia | 23294 | United States |
| National Center for Geriatrics and Gerontology | Ōbu | Aichi-ken | 474-8511 | Japan |
| National Hospital Organization Hiroshima-Nishi Medical Center | Ōtake | Hiroshima | 739-0696 | Japan |
| Keimei Memorial Hospital | Honjō | Miyazaki | 880-1111 | Japan |
| Rijikai Medical Corporation Katayama Medical Clinic | Kurashiki | Okayama-ken | 710-0813 | Japan |
| Tokyo Medical University Hospital | Shinjuku | Tokyo | 160-0023 | Japan |
| Keio University Hospital | Shinjuku | Tokyo | 160-8582 | Japan |
| Osaka Metropolitan University Hospital | Osaka | 545-8586 | Japan |
| Yamagata Tokushukai Hospital | Yamagata | 990-0834 | Japan |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000612089 | lecanemab |
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