A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Early Alzheimer's Disease Clinical Trial

— Clarity AD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03887455
• Other study ID #: BAN2401-G000-301
• Secondary ID: 2018-004739-58
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 27, 2019
• Est. completion date: September 15, 2027

Study information

• Verified date: June 2023
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

Description:

All administrations of study drug will be administered in the clinic; However, home administrations of study drug will be allowed per sponsor approval according to country and local guidelines during the COVID-19 pandemic and following its resolution, where permitted.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1906
• Est. completion date: September 15, 2027
• Est. primary completion date: September 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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 (except de novo participants)

• 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

• Participants entering the subcutaneous (vial) substudy at Extension Phase Week 1, must be willing to participate, or continue participating in the amyloid positron emission tomography (PET) substudy. All participants must have an amyloid PET scan within 4 weeks before starting subcutaneous BAN2401.

• Participants enrolling into the subcutaneous autoinjector substudy must have had at least 6 months exposure to BAN2401 10 mg/kg intravenously (IV) biweekly or BAN2401 720 mg subcutaneously (SC) weekly.

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 ß-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 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

• 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 will be exclusionary if based on the opinion of the investigator, with consultation of medical monitor, these findings may interfere with the study procedures or safety

• Hypersensitivity to BAN2401 or any of the excipients, or to any monoclonal antibody treatment

• Any immunological disease which is not adequately controlled, or which requires chronic treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study

• Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG, which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety.

• Malignant neoplasms (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male participants) that are not stably and adequately controlled or which, based on the opinion of the investigator, may interfere with the participant's safety or participation in 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

• Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately

Related Conditions & MeSH terms

• Alzheimer Disease
• Early Alzheimer's Disease

Intervention

Drug:
• Lecanemab
10 milligram per kilogram (mg/kg) biweekly (once every 2 weeks) administered as i.v. infusion.
• Placebo
Biweekly (once every 2 weeks) administered as i.v. infusion.
• Lecanemab
720 milligram (mg) weekly administered as subcutaneous injection.

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital/Internal Medicine & Dementia Research Unit	Chermside Brisbane	Queensland
Australia	St Vincent's Hospital - Translational Research Centre	Darlinghurst	New South Wales
Australia	Austin Health - Medical and Cognitive Research Unit	Ivanhoe	Victoria
Australia	KaRa Institute of Neurological Diseases	Macquarie Park	New South Wales
Australia	HammondCare Malvern Clinical Trials Unit	Malvern	Victoria
Australia	Australian Alzheimer's Research Foundation	Nedlands	Western Australia
Australia	Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital	Woodville South, Adelaid	South Australia
Canada	Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais	Gatineau	Quebec
Canada	MoCA Clinic and Institute/NeuroSearch Developpements Inc.	Greenfield Park	Quebec
Canada	True North Clinical Research Halifax, Inc.	Halifax	Nova Scotia
Canada	Okanagan Clinical Trials	Kelowna	British Columbia
Canada	True North Clinical Research Kentville, Inc.	Kentville	Nova Scotia
Canada	St. Joseph's HC- Parkwood Institute	London	Ontario
Canada	Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic	Ottawa	Ontario
Canada	Kawartha Centre - Redefining Healthy Aging	Peterborough	Ontario
Canada	Q&T Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Toronto Memory Program (Neurology Research Inc.)	Toronto	Ontario
Canada	Health Research	West Vancouver	British Columbia
China	Baotou Central Hospital	Baotou	Inner Mongolia Autonomous Region
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Guangdong Provincial People's Hospital	Guangzhou	Guangzhou
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Guangzhou Huiai Hospital	Guangzhou	Guangdong
China	Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Nanjing Brain Hospital, Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Renji Hospital Shanghai Jiaotong Universtiy School of Medicine	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Qinghai Provincial People's Hospital	Xining	Qinghai
China	Henan Provincial People's Hospital	Zhengzhou	Henan
France	Hôpital neurologique Pierre Wertheimer	Bron Cedex
France	Hopital de la Timone	Marseille	Cedex 05
France	Hôpital Gui de Chauliac	Montpellier	Cedex 5
France	Hopital Guillaume et Renà LaÃnnec	Nantes	Cedex
France	Groupe Hospitalier Pitie-Salpetriere	Paris	Cedex
France	Hôpital Lariboisière	Paris cedex 10	Paris
France	Hôpital de Hautepierre	Strasbourg Cedex	Bas Rhin
France	Centre de Recherche Clinique du Gérontopôle	Toulouse	Haute Garonne
Germany	Eisai Trial Site #6	Berlin
Germany	Eisai Trial Site #1	Bielefeld
Germany	Eisai Trial Site #4	Erbach
Germany	Eisai Trial Site #5	Günzburg	Baden Wuerttemberg
Germany	Eisai Trial Site #2	Mannheim	Baden-Wurttemberg
Germany	Eisai Trial Site #3	Munchen
Italy	Fondazione Istituto G.Giglio di Cefalù	Cefalu	Palermo
Italy	Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova	Genova
Italy	Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative	Milano
Italy	ASST-Monza, Ospedale San Gerardo	Monza
Italy	Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"	Napoli
Italy	Ospedale S. Maria della Misericordia, S. Andrea delle Fratte	Perugia
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Fondazione Policlinico Agostino Gemelli - UCSC	Roma
Italy	Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane	Roma
Italy	Ospedale "Card. G. Panico" -	Tricase	LE
Japan	Eisai Trial Site #7	Atsugi-shi	Kanagawa
Japan	Eisai Trial Site #29	Bunkyo-ku	Tokyo
Japan	Eisai Trial Site #5	Bunkyo-ku	Tokyo
Japan	Eisai Trial Site #15	Chiba-shi	Chiba
Japan	Eisai Trial Site #1	Fujioka-shi	Gunma
Japan	Eisai Trial Site #17	Fujisawa-shi	Kanagawa
Japan	Eisai Trial Site #13	Hachioji-shi	Tokyo
Japan	Eisai Trial Site #33	Higashimorokatagun	Miyazaki
Japan	Eisai Trial Site #28	Himeji-shi	Hyogo
Japan	Eisai Trial Site #8	Hirakata	Osaka
Japan	Eisai Trial Site #21	Hofu	Yamaguchi
Japan	Eisai Trial Site #9	Kahoku	Ishikawa
Japan	Eisai Trial Site #20	Kawasaki-shi	Kanagawa
Japan	Eisai Trial Site #19	Kobe-shi	Hyogo
Japan	Eisai Trial Site #16	Kurashiki-shi	Okayama
Japan	Eisai Trial Site #12	Musashino-shi	Tokyo
Japan	Eisai Trial Site #22	Niigata-shi	Niigata
Japan	Eisai Trial Site #4	Obu-shi	Aichi
Japan	Eisai Trial Site #11	Osaka
Japan	Eisai Trial Site #27	Osaka
Japan	Eisai Trial Site #32	Otake	Hiroshima
Japan	Eisai Trial Site #31	Otsu-shi	Shiga
Japan	Eisai Trial Site #18	Saitama-shi	Saitama
Japan	Eisai Trial Site #30	Sapporo-shi	Hokkaido
Japan	Eisai Trial Site #23	Shinagawa-ku	Tokyo
Japan	Eisai Trial Site #10	Shinjuku-ku	Tokyo
Japan	Eisai Trial Site #25	Shinjuku-ku	Tokyo
Japan	Eisai Trial Site #26	Suita-shi	Osaka
Japan	Eisai Trial Site #24	Toride-shi	Ibaraki
Japan	Eisai Trial Site #14	Ube-shi	Yamaguchi
Japan	Eisai Trial Site #3	Yamagata-shi	Yamagata
Japan	Eisai Trial Site #2	Yokohama-shi	Kanagawa
Japan	Eisai Trial Site #6	Yoshida-gun	Fukui
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Chonnam National University Hospital	Gwangju	Jeolla-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Seoul
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Russian Federation	First Moscow State Medical University n.a. I.M. Sechenov	Moscow
Singapore	National University Hospital	Singapore
Spain	Fundacion ACE, Barcelona	Barcelona
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Santa Cruz y San Pablo	Barcelona
Spain	Hospital Universitario Reina Sofía	Cordoba
Spain	Fundación CITA-alzheimer Findazioa	Donostia San Sebastian	Gipuzkoa
Spain	Centro CAE Oroitu	Getxo	Bizkaia
Spain	Complejo Hospitalario Ruber Juan Bravo	Madrid
Spain	Hospital de Salamanca	Salamanca
Spain	Policlinica Guipuzcoa	San Sebastian	Guipuzcoa
Spain	Hospital General de Catalunya	Sant Cugat del Valles	Barcelona
Spain	Hospital Victoria Eugenia - Cruz Roja	Sevilla
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Sweden	Sahlgrenska University Hospital	Gothenburg	Västra Götalandslän
Sweden	Memory Clinic, Malmö University Hospital	Malmö
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hospital, Uppsala	Uppsala
United Kingdom	Re:Cognition Health Ltd	Birmingham
United Kingdom	Re:Cognition Health Ltd	Guildford
United Kingdom	Charing Cross Hospital	London
United Kingdom	Re:Cognition Health Ltd	London
United Kingdom	St. Pancras Clinical Research	London
United Kingdom	Re:Cognition Health	Plymouth	Devon
United Kingdom	Sheffield Memory Service	Sheffield	South Yorkshire
United Kingdom	Memory Assessment & Research Centre (MARC),	Southampton	Hampshire
United States	Albany Medical College	Albany	New York
United States	Neurological Associates of Albany, PC	Albany	New York
United States	Emory University Cognitive Neurology Clinic & ADRC	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	Senior Adult Specialty Research	Austin	Texas
United States	Partners Population Health	Belmont	Massachusetts
United States	DBA The Memory Clinic	Bennington	Vermont
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Bradenton Research Center, Inc.	Bradenton	Florida
United States	OH Clinical Research Partners	Canton	Ohio
United States	ImmunoE Research Center	Centennial	Colorado
United States	ANI Neurology, PLLC d/b/a Alzheimer's Memory Center	Charlotte	North Carolina
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Columbs Neuroscience, LLC	Columbus	Ohio
United States	Columbus Memory Center	Columbus	Georgia
United States	Ohio State University	Columbus	Ohio
United States	Advanced Clinical Research Network	Coral Gables	Florida
United States	Linfritz Research Institute, Inc.	Coral Gables	Florida
United States	Neurology Clinic, P.C.	Cordova	Tennessee
United States	Kerwin Research Center	Dallas	Texas
United States	Texas Neurology, PA	Dallas	Texas
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	NeuroStudies.net, LLC	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Mile High Research Center	Denver	Colorado
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Associated Neurologists of Southern Connecticut	Fairfield	Connecticut
United States	Neuropsychiatric Research Center of Southwest FL	Fort Myers	Florida
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Neurology Center of North Orange County	Fullerton	California
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Infinity Clinical Research	Hollywood	Florida
United States	Hawaii Pacific Neuroscience	Honolulu	Hawaii
United States	Baylor College of Medicine AD and Memory Disorders Center	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Irvine Clinical Research	Irvine	California
United States	University of Kansas Medical Center Research Institute	Kansas City	Kansas
United States	Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company	Knoxville	Tennessee
United States	Charter Research	Lady Lake	Florida
United States	Alzheimer's Research and Treatment Center	Lake Worth	Florida
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	University of California - Los Angeles	Los Angeles	California
United States	Clincloud, LLC	Maitland	Florida
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	Allied Biomedical Research (Clinical Trial)	Miami	Florida
United States	BioMed Research Institute	Miami	Florida
United States	CCM Clinical Research Group	Miami	Florida
United States	Finlay Medical Research	Miami	Florida
United States	Gonzalez MD & Aswad MD Health Services	Miami	Florida
United States	Miami Jewish Health Systems	Miami	Florida
United States	Pharmax Research of South Florida, Inc	Miami	Florida
United States	Rios Medical Center, Inc.	Miami	Florida
United States	Visionary Investigators Network	Miami	Florida
United States	Visionary Investigators Network	Miami	Florida
United States	Vitae Research Center	Miami	Florida
United States	Galiz Research	Miami Springs	Florida
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Neurological Institute of New York	New York	New York
United States	New York University Medical Center PRIME	New York	New York
United States	Boston Center for Memory	Newton	Massachusetts
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	Roper St. Francis Healthcare	North Charleston	South Carolina
United States	Research Center for Clinical Studies, Inc.	Norwalk	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Bioclinica Research	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Pacific Neuroscience Medical Group	Oxnard	California
United States	Advanced Research Consultants, Inc.	Palm Beach Gardens	Florida
United States	IMIC, Inc.	Palmetto Bay	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute- Clinical Trials Department	Phoenix	Arizona
United States	Donald S. Marks, MD. P.C.	Plymouth	Massachusetts
United States	Quantum Laboratories Inc.	Pompano Beach	Florida
United States	Neurostudies, Inc.	Port Charlotte	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Coastal Neurology, P.A.	Port Royal	South Carolina
United States	Neural Net Research, LLC	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Summit Research Network (OR) Inc.	Portland	Oregon
United States	Butler Hospital - Memory and Aging Program	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Raleigh Neurology Associates, P.A. - Research Department	Raleigh	North Carolina
United States	National Clinical Research Inc.-Richmond	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	Pacific Research Network, Inc	San Diego	California
United States	Sharp Mesa Vista Hospital	San Diego	California
United States	UCSF Memory and Aging Center	San Francisco	California
United States	Apex Research Institute	Santa Ana	California
United States	St Joseph Heritage Healthcare	Santa Rosa	California
United States	North Bay Neuroscience Research Institute	Sebastopol	California
United States	Kingfisher Cooperative LLC	Spokane	Washington
United States	Alzheimer's Research and Treatment Center	Stuart	Florida
United States	Banner Sun Health Research	Sun City	Arizona
United States	Infinity Clinical Research, LLC	Sunrise	Florida
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	USF Suncoast Gerontology Center	Tampa	Florida
United States	Bioclinica Research	The Villages	Florida
United States	Advanced Memory Research Institute of NJ, PC	Toms River	New Jersey
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Neurological Associates of Tucson dba Center for Neurosciences	Tucson	Arizona
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Premiere Research Institute, West Palm	West Palm Beach	Florida
United States	KU Wichita Center for Clinical Research	Wichita	Kansas
United States	PMG Research of Winston Salem	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Biogen

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Russian Federation,  Singapore,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Study: Change from Baseline in the CDR-SB at 18 Months		Baseline, 18 months
Primary	Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	A TEAE is defined as an adverse event that emerges during treatment or within 30 days of the last dose of study drug, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) were reported based on their regular measurement of vital signs, safety assessments of laboratory tests, antidrug antibody assessments, suicidality assessments, magnetic resonance imaging and electrocardiogram parameter values.	From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase
Primary	Extension Phase: Change from Core Study Baseline in CDR-SB		Baseline up to Month 69
Secondary	Core Phase: Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at 18 Months		Baseline, 18 months
Secondary	Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months		Baseline, 18 months
Secondary	Core Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months		Baseline, 18 months
Secondary	Core Study: Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL) at 18 Months		Baseline, 18 months