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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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Enrolling by invitation NCT06304883 - Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects Phase 3