A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03887455 |
Recruitment Status :
Recruiting
First Posted : March 25, 2019
Last Update Posted : November 23, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Early Alzheimer's Disease | Drug: Lecanemab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1566 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease |
Actual Study Start Date : | March 27, 2019 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | August 29, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Core Study: Lecanemab 10 mg/kg biweekly |
Drug: Lecanemab
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
Other Name: BAN2401 |
Placebo Comparator: Core Study: Placebo |
Drug: Placebo
Biweekly (once every 2 weeks) administered i.v. infusion. |
Experimental: Extension Phase: Lecanemab 10 mg/kg biweekly |
Drug: Lecanemab
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
Other Name: BAN2401 |
- Core Study: Change from Baseline in the CDR-SB at 18 Months [ Time Frame: Baseline, 18 months ]
- Extension Phase: Number of Participants With Adverse Events (AEs), Clinically Significant Change From Baseline in Vital Signs Values, Abnormal MRI and ECG Values, Clinically Significant Findings in Laboratory Values, Positive ADAs, and any Suicidality [ Time Frame: Month 18 up to Month 45 ]Here MRI means magnetic resonance imaging, ECG means electrocardiogram, and ADAs means antidrug antibodies.
- Extension Phase: Change from Core Study Baseline in CDR-SB [ Time Frame: Baseline up to Month 45 ]
- Core Study: Change from Baseline in the Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) Composite at 18 Months [ Time Frame: Baseline, 18 months ]
- Core Study: Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months [ Time Frame: Baseline, 18 months ]
- Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months [ Time Frame: Baseline, 18 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Core Study: Inclusion Criteria
Diagnosis: Mild Cognitive Impairment (MCI) due to Alzheimer's disease - intermediate likelihood:
- Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to Alzheimer's disease - intermediate likelihood
- Have a global Clinical Dementia Rating (CDR) score of 0.5 and CDR Memory Box score of 0.5 or greater at Screening and Baseline
- Report a history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening; must be corroborated by an informant
Mild Alzheimer's disease dementia:
- Meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
- Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline
Key Inclusion Criteria that must be met by all participants:
- Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II (WMS-IV LMII)
- Positive biomarker for brain amyloid pathology
- Male or female participants aged greater than or equal to (>=) 50 and less than or equal to (<=) 90 years, at the time of informed consent
- Mini mental state examination (MMSE) score >=22 at Screening and Baseline and <=30 at Screening and Baseline
- Body mass index (BMI) greater than (>)17 and less than (<) 35 at Screening
- If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 12 weeks prior to Baseline. Treatment-naive participants for Alzheimer's disease can be entered into the study. Unless otherwise stated, participants must have been on stable doses of all other (that is, non-Alzheimer's disease-related) permitted concomitant medications for at least 4 weeks prior to Baseline. Use of memantine will not be allowed 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 capacity to consent in the investigator's opinion, the participant's 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). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study (example, Germany and Spain), they will not be enrolled
Extension Phase: Inclusion Criteria:
- Participants who have completed the Core Study
- Have a BMI >17 and <35
- Must continue to have a study partner who is willing and able to provide follow-up information on the participant throughout the course of the Extension Phase
- Provide written informed consent for the Extension Phase. If a participant lacks capacity to consent in the investigator's opinion, the participant's assent should be obtained, if required and 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). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study (example, Germany and Spain), they will not be enrolled
Exclusion Criteria
- Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease
- History of transient ischemic attacks (TIA), 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 participant
- Geriatric Depression Scale (GDS) score >=8 at 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 Alzheimer's disease
- Other significant pathological findings on brain MRI at screening, including but not limited to: more than 4 microhemorrhages (defined as 10 millimeter [mm] or less at the greatest diameter); a single macrohemorrhage >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 <1 centimeter [cm] at their greatest diameter need not be exclusionary)
- Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
- Participants with a bleeding disorder that is not under adequate control (including a platelet count <50,000 or international normalized ratio [INR] >1.5 for participants who are not on anticoagulant treatment, example, warfarin). Participants who are on anticoagulant therapy should have their anticoagulant status optimized and be on a stable dose for 4 weeks before Screening. Participants who are on anticoagulant therapy are not permitted to participate in cerebrospinal fluid (CSF) assessments
- Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
- Participation in a clinical study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months before screening unless it can be documented that the participant was randomized to placebo
- Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapies and any β-site amyloid precursor protein cleaving enzyme [BACE] inhibitor therapies) unless it can be documented that the participant only received placebo
- Participants who have any known prior exposure to lecanemab
- Participants who were dosed in a clinical study involving any new chemical entities for Alzheimer's disease (AD) within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm
Extension Phase: Exclusion Criteria
- Participants who discontinued early from the Core Study
-
Participants who develop the following conditions from the time of Screening for the Core Study to the start of the Extension Phase
- TIA, stroke, or seizures
- Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
- Any psychiatric diagnosis or symptoms, (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
- 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)
- Other significant pathological findings on brain MRI during the Core Study including but not limited to: 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 <1 cm at their greatest diameter need not be exclusionary
- Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
- Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887455
Contact: Eisai Medical Information | 1-888-274-2378 | esi_medinfo@eisai.com |

Responsible Party: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT03887455 |
Other Study ID Numbers: |
BAN2401-G000-301 2018-004739-58 ( EudraCT Number ) |
First Posted: | March 25, 2019 Key Record Dates |
Last Update Posted: | November 23, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
BAN2401 Clinical Dementia Rating-Sum of Boxes Mild cognitive impairment Alzheimer's disease/prodromal Alzheimer's disease |
Mild Alzheimer's disease dementia Clarity AD Lecanemab |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |