AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,400

Participants

Timeline

Start Date

July 14, 2020

Primary Completion Date

December 21, 2028

Study Completion Date

January 16, 2031

Conditions
Preclinical Alzheimer's DiseaseEarly Preclinical Alzheimer's Disease
Interventions
DRUG

Lecanemab

IV infusion.

DRUG

Placebo

IV infusion.

Trial Locations (109)

6009

Alzheimer's Research Australia, Nedlands

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University, New York

14620

University of Rochester, Rochester

15213

University of Pittsburgh, Pittsburgh

19001

Abington Neurological Associates, Abington

19104

University of Pennsylvania, Philadelphia

19403

Keystone Clinical Studies, LLC, Norristown

20009

Fundacion CITA ALZHEIMER, Donostia / San Sebastian

20057

Georgetown University, Washington D.C.

20060

Howard University, Washington D.C.

20403

Ralph H. Johnson VA Medical Center, Charleston

21155

Brigham and Woman's Hospital Center for Alzheimer Research and Treatment, Boston

21224

Johns Hopkins University, Baltimore

23294

National Clinical Research, Inc, Richmond

23507

Eastern Virginia Medical School, Norfolk

27157

Wake Forest University Health Sciences, Winston-Salem

27705

Duke Health Center, Durham

28105

AMC Research, Matthews

28223

Hospital Universitario Quirón Salud Madrid, Madrid

29403

Ralph H. Johnson VA Medical Center, Charleston

30329

Emory University, Atlanta

31792

Charter Research, Winter Park

31909

Columbus Memory Center, PC, Columbus

32159

K2 Medical Research - The Villages, Lady Lake

32162

Synexus Clinical Research, The Villages

32224

Mayo Clinic Jacksonville, Jacksonville

32751

K2 Medical Research, Llc, Maitland

K2 Medical Research, Maitland

32806

Synexus Clinical Research, Orlando

33125

Gonzalez MD & Aswad MD Health Sciences, Miami

33140

Wien Center for Clinical Research, Miami Beach

33414

Alzheimer's Research and Treatment Center, Wellington

33445

Brain Matters Research, Delray Beach

33613

University of South Florida - Health Byrd Alzheimer Institute, Tampa

34470

Renstar Medical Research, Ocala

35233

University of Alabama, Birmingham, Birmingham

37212

Vanderbilt University Medical Center, Nashville

39008

Hospital Universitario Marqués de Valdeciila, Santander

40504

University of Kentucky, Lexington

43210

Ohio State University, Columbus

44122

Case Western Reserve University/University Hospitals, Beachwood

44195

Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland

46202

Indiana University School of Medicine, Indianapolis

48105

University of Michigan (UMICH), Ann Arbor

53792

University of Wisconsin, Madison

55905

Mayo Clinic, Rochester, Rochester

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

63108

Washington University, St Louis

66205

University of Kansas, Fairway

74136

Central States Research, LLC, Tulsa

75390

University of Texas, Southwestern MC at Dallas, Dallas

76107

University of North Texas Health Sciences Center, Fort Worth

77030

Baylor College of Medicine, Houston

Houston Methodist Neurological Institute, Houston

85006

Banner Alzheimer's Institute, Phoenix

85351

Banner Sun Health Research Institute, Sun City

89106

Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas

90033

University of Southern California, Los Angeles

92123

Sharp Mesa Vista Hospital, San Diego

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

94158

Univeristy of California, San Francisco, San Francisco

94304

Stanford University, Palo Alto

94598

University of California, Davis, Walnut Creek

97210

Summit Research Network, Oregon, Portland

97239

Oregon Health & Science University, Portland

98104

University of Washington Memory and Brain Wellness Center, Seattle

98108

SIBCR, Seattle

92697-4285

UCI MIND, Irvine

06510

Yale University School of Medicine, New Haven

33134-1613

Advanced Clinical Research Network, Corp, Coral Gables

02118

Boston University, Boston

02360

Donald S.Marks, M.D.,P.C., Plymouth

08755

Advanced Memory Research Institute of New Jersey, Toms River

02903

Rhode Island Hospital, Providence

02906

Butler Hospital Memory and Aging Program, Providence

78229-3900

The University of Texas Health Science Center at San Antonio, San Antonio

Unknown

St Vincent's Hospital Sydney, Darlinghurst

Calvary Mater Newcastle, Waratah

Westmead Hospital, Westmead

CALHN Memory Trials, Adelaide

Austin Hospital - Medical and Cognitive Research Unit, Ivanhoe

National Center for Geriatrics and Gerontology, Obu-shi

Fukuoka University Hospital, Fukuoka

Shonan Kamakura General Hospital, Kamakura-shi

Koseikai Takeda Hospital, Kyoto

Tohoku University Hospital, Sendai

Medical Corporation Heishinkai OPHAC Hospital, Osaka

Medical Corporation Heishinkai OPHAC Hospital, Suita-shi

The University of Tokyo Hospital, Bunkyo-ku

P-One Clinic, Keikokai Medical Corporation, Hachioji -shi

Tokyo Metropolitan Geriatric Hospital, Itabashi-ku

National Center of Neurology and Psychiatry, Kodaira-shi

ICR Clinical Research Hospital Tokyo, Shinjuku-Ku

National University Hospital, Singapore

B3S 1L8

Centricity Research, Hailfax

B4N 3R7

True North Clinical Research Inc., New Minas

True North Clinical Research, New Minas

N6C0A7

Parkwood Institute Main Building, London

M3B 2S7

Toronto Memory Program, Toronto

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

650-0017

Kobe University Hospital, Kobe

08005

Barcelona Beta Brain Research Center, Barcelona

08028

Fundació ACE, Barcelona

BS10 5NB

Bristol Brain Centre, Bristol

ML1 4UF

Glasgow Memory Clinic, Glasgow

EC2Y 8EA

St Pancras Clinical Research, London

W6 8RF

Imperial Memory Unit, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alzheimer's Clinical Trials Consortium

OTHER

collaborator

Biogen

INDUSTRY

collaborator

National Institute on Aging (NIA)

NIH

lead

Eisai Inc.

INDUSTRY