Phase
Condition
Memory Loss
Alzheimer's Disease
Dementia
Treatment
E2814
Placebo
Lecanemab
Clinical Study ID
Ages 50-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For participants diagnosed with mild cognitive impairment (MCI) due toAD-intermediate likelihood:
Meet the National Institute on Aging-Alzheimer's Association (NIA-AA) coreclinical criteria for MCI due to AD-intermediate likelihood.
Have a global Clinical Dementia Rating Scale (CDR) score of 0.5 and a CDRMemory Box score of greater than or equal to (>=) 0.5 at Screening and Baseline
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 atScreening and Baseline
Mini Mental State Examination (MMSE) score >=22 at Screening and Baseline and lessthan or equal to (<=) 30 at Screening and Baseline
Able to have CSF lumbar puncture performed and not on, or have a medical conditionthat may require initiation of, any anticoagulant therapy at Screening
Male or female participants aged between >=50 years and <=80 years, at the time ofinformed consent
If receiving an approved AD symptomatic treatment (such as acetylcholinesteraseinhibitors (AchEIs), memantine, or both) for AD, participants must be on a stabledose for at least 12 weeks before Visit 1. Treatment-naïve participants for ADmedications can be enrolled into the study. Unless otherwise stated, participantsmust have been on stable doses of all other (that is, non AD-related) permittedconcomitant medications for at least 4 weeks before Baseline. Use of memantine willnot be allowed at screening for participants in Japan
Have an identified study partner (defined as a person able to support theparticipant for the duration of the study and who spends at least 8 hours per weekwith the participant).
Provide written informed consent. If a participant lacks the capacity to consent inthe Investigator's opinion, the participants' assent should be obtained, if requiredin accordance with local laws, regulations, and customs, plus the written informedconsent of a legal representative should be obtained (capacity to consent anddefinition of legal representative should be determined in accordance withapplicable local laws and regulations)
Willing and able to comply with all aspects of the protocol including multiple CSFcollections
Exclusion
Exclusion Criteria:
Any neurological condition that may be contributing to cognitive impairment aboveand beyond that caused by the participant's AD
History of transient ischemic attacks, stroke, or seizures within 12 months ofScreening
Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, ordelusions) that could interfere with study procedures in the participants. Psychoticdisorder(s) or unstable recurrent affective disorder(s) evident by use ofantipsychotics within 2 years before Screening
Contraindications to MRI scanning, including cardiac pacemaker/defibrillator,ferromagnetic metal implants (example, in skull and cardiac devices other than thoseapproved as safe for use in MRI scanners). Evidence of other clinically significantlesions on brain MRI at Screening that could indicate a dementia diagnosis otherthan AD. Other significant pathological findings on brain MRI at Screening,including but not limited to: greater than 4 microhemorrhages (defined as 10millimeter (mm) or less at the greatest diameter); a single intracerebral hemorrhagegreater than 10 mm at greatest diameter; an area of superficial siderosis; evidenceof vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms,vascular malformations, or infective lesions; evidence of multiple lacunar infarctsor stroke involving a major vascular territory, severe small vessel, or white matterdisease; space occupying lesions; or brain tumors (however, lesions diagnosed asmeningiomas or arachnoid cysts and less than 1 cm at their greatest diameter neednot be exclusionary). Other minor or clinically insignificant magnetic resonanceimaging (MRI) abnormalities, as agreed by the medical monitor and after discussionwith the investigator, may not be exclusionary
Malignant neoplasms within 3 years of Screening (except for basal or squamous cellcarcinoma in situ of the skin, or localized prostate cancer in male participants, orlocalized breast cancer in female participants). Participants who had malignantneoplasms but who have had at least 3 years of documented uninterrupted remissionbefore Screening need not be excluded
A clinically significant ECG abnormality, including a marked prolonged corrected QTinterval (Fridericia's Correction Formula; QTcF) interval (example, a repeateddemonstration of a QTcF interval greater than (>) 450 milliseconds [ms])
Participants with a bleeding disorder that is not under adequate control (includinga platelet count <50,000 or international normalized ratio [INR] >1.5). Anyparticipants who are on anticoagulant therapy are not permitted to be enrolled
Have thyroid-stimulating hormone above normal range. Other tests of thyroid functionwith results outside the normal range should only be exclusionary if they areconsidered clinically significant by the investigator. This applies to allparticipants whether or not they are taking thyroid supplements
Abnormally low serum vitamin B12 levels for the testing laboratory (if participantis taking vitamin B12 injections, level should be at or above the lower limit ofnormal for the testing laboratory). Levels of vitamin B12 may be confirmed withreflex testing to include methylmalonic acid analysis, if available in region
Any suicidal ideation with intent with or without a plan at Screening, Baseline, orwithin 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on theSuicidal 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 forsuicidal 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. Anyother medical conditions (example, cardiac, respiratory, gastrointestinal, and renaldisease) that are not stably and adequately controlled or that in the opinion of theinvestigator(s) could affect the participant's safety or interfere with the studyassessments
Hypersensitivity to lecanemab, E2814, or any of the excipients
Any immunological disease, that is not adequately controlled, or that requirestreatment with immunoglobulins, systemic monoclonal antibodies (mAbs) (orderivatives of mAbs), systemic immunosuppressants, or plasmapheresis during thestudy
Any history of or concomitant medical condition that in the opinion of theinvestigator(s) would compromise the participant's ability to safely complete thestudy
Planned surgery that requires general, spinal, or epidural anesthesia that wouldtake place during the study. Planned surgery that requires only local anesthesia andthat can be undertaken as a day case without inpatient stay postoperatively need notresult in exclusion if in the opinion of the investigator this operation does notinterfere 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 yearsbefore Screening or a positive urine drug test at Screening. Participants who testpositive for benzodiazepines or opioids in urine drug testing need not be excludedif in the clinical opinion of the investigator, this is due to the participanttaking prior/concomitant medications containing benzodiazepines or opioids for amedical condition and not due to drug abuse
Severe visual or hearing impairment that would prevent the participant fromperforming psychometric tests accurately
Study Design
Connect with a study center
National Center for Geriatrics and Gerontology
Obu, Aichi 474-8511
JapanActive - Recruiting
National Hospital Organization Hiroshima-Nishi Medical Center
Otake, Hiroshima 739-0696
JapanActive - Recruiting
Keimei Memorial Hospital
Higashimorokatagun, Miyazaki 880-1111
JapanActive - Recruiting
Rijikai Medical Corporation Katayama Medical Clinic
Kurashiki, Okayama 710-0813
JapanActive - Recruiting
Nippon Medical School Hospital
Kanagawa, 2118533
JapanActive - Recruiting
Osaka Metropolitan University Hospital
Osaka, 545-8586
JapanSite Not Available
Keio University Hospital
Tokyo, 160-8582
JapanSite Not Available
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanSite Not Available
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Tokyo, 1730015
JapanSite Not Available
Yamagata Tokushukai Hospital
Yamagata, 9900834
JapanActive - Recruiting
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
Sharp Neurocognitive Research Center at Sharp Mesa Vista Hospital
San Diego, California 92123
United StatesSite Not Available
University of California at San Francisco/UCSF
San Francisco, California 94158-2549
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
Bradenton Research Center
Bradenton, Florida 34205
United StatesActive - Recruiting
K2 Medical Research
Clermont, Florida 34711
United StatesActive - Recruiting
Charter Research
Lady Lake, Florida 32159
United StatesActive - Recruiting
Advanced Clinical Research Network
Miami, Florida 33135
United StatesActive - Recruiting
Renstar Medical Research
Ocala, Florida 34470
United StatesActive - Recruiting
Progressive Medical Research
Port Orange, Florida 32127
United StatesActive - Recruiting
Alzheimer's Research and Treatment Center
Stuart, Florida 34997
United StatesActive - Recruiting
Axiom Brain Health
Tampa, Florida 33609
United StatesSite Not Available
ClinCloud Research, LLC
Viera, Florida 32940
United StatesActive - Recruiting
Alzheimer's Research and Treatment Center
Wellington, Florida 33414
United StatesActive - Recruiting
Columbus Memory Center, PC
Columbus, Georgia 31909
United StatesSite Not Available
Memory Center/Hattiesburg Clinic
Hattiesburg, Mississippi 39401
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Advanced Memory Research Institute
Toms River, New Jersey 08755
United StatesSite Not Available
AMC Research LLC, Formerly Alzheimer's Memory Center
Matthews, North Carolina 28105
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44113
United StatesSite Not Available
Abington Neurological Associates Ltd
Abington, Pennsylvania 19001
United StatesActive - Recruiting
Keystone Clinical Research LLC
Plymouth Meeting, Pennsylvania 19462
United StatesActive - Recruiting
Neurology Clinical, P.C.
Cordova, Tennessee 38018
United StatesActive - Recruiting
Kerwin Medical Center
Dallas, Texas 75231-4350
United StatesActive - Recruiting
National Clinical Research-Richmond, Inc
Richmond, Virginia 23294
United StatesActive - Recruiting
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