A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

856

Participants

Timeline

Start Date

December 20, 2012

Primary Completion Date

December 10, 2024

Study Completion Date

December 10, 2024

Conditions
Alzheimer's Disease
Interventions
DRUG

Lecanemab 2.5 mg/kg

2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion

DRUG

Lecanemab 5.0 mg/kg

5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion

DRUG

Lecanemab 10 mg/kg

10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.

DRUG

Lecanemab 5.0 mg/kg

5.0 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401

DRUG

Lecanemab 10 mg/kg

10 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401

DRUG

Placebo

biweekly (once every 2 weeks) administered as i.v. infusion

DRUG

Lecanemab 10 mg/kg

10 mg/kg biweekly (once every 2 weeks), once every 4 weeks (Q4W) or once every 3 months (Q3M) i.v. infusion.

Trial Locations (169)

10016

Facility #1, New York

10021

Facility #2, New York

12110

Facility #1, Latham

12206

Facility #1, Albany

14226

Facility #1, Amherst

14620

Facility #1, Rochester

14623

Facility #2, Rochester

19001

Facility #1, Abington

19046

Facility #1, Jenkintown

23294

Facility #1, Richmond

28211

Facility #1, Charlotte

30033

Facility #1, Decatur

30308

Facility #2, Atlanta

30329

Facility #1, Atlanta

31909

Facility #1, Columbus

32806

Facility #1, Orlando

33009

Facility #1, Hallandale

33016

Facility #1, Hialeah

33064

Facility #1, Deerfield Beach

33133

Facility #1, Miami

33137

Facility #2, Miami

33145

Facility #3, Miami

33166

Facility #1, Miami Springs

33351

Facility #1, Sunrise

33410

Facility #1, Palm Beach Gardens

33431

Facility #1, Boca Raton

33445

Facility #1, Delray Beach

33449

Facility #1, Lake Worth

33462

Facility #1, Atlantis

33486

Facility #2, Boca Raton

33609

Facility #3, Tampa

33613

Facility #1, Tampa

Facility #2, Tampa

33713

Facility #1, St. Petersburg

33912

Facility #1, Fort Myers

34102

Facility #1, Naples

34205

Facility #1, Bradenton

34471

Facility #1, Ocala

34748

Facility #1, Leesburg

34749

Facility #2, Leesburg

35294

Facility #1, Birmingham

37920

Facility #1, Knoxville

40504

Facility #1, Lexington

45459

Facility #1, Centerville

46202

Facility #1, Indianapolis

46514

Facility #1, Elkhart

48322

Facility #1, West Bloomfield

48334

Facility #1, Farmington Hills

48824

Facility #1, Lansing

53226

Facility #1, Milwaukee

60007

Facility #1, Elk Grove Village

60640

Facility #1, Chicago

63118

Facility #1, St Louis

67214

Facility #1, Wichita

73112

Facility #1, Oklahoma City

73116

Facility #2, Oklahoma City

75214

Facility #1, Dallas

77074

Facility #1, Houston

78229

Facility #1, San Antonio

Facility #2, San Antonio

Facility #3, San Antonio

78757

Facility #1, Austin

85004

Facility #1, Phoenix

85724

Facility #1, Tucson

90024

Facility #1, Los Angeles

Facility #2, Los Angeles

Facility #3, Los Angeles

90717

Facility #1, Lomita

90720

Facility #1, Los Alamitos

90746

Facility #1, Carson

90806

Facility #1, Long Beach

92123

Facility #1, San Diego

93030

Facility #1, Oxnard

97210

Facility #2, Portland

97239

Facility #1, Portland

Unknown

Facility #1, Orange

Facility #1, The Villages

Facility #1, East Lansing

Facility #2, Dallas

Facility #1, Kentville

Facility #1, Kingston

Facility #2, London

Facility #1, Ottawa

Facility #1, Peterborough

Facility #1, Toronto

Facility #1, Greenfield Park

Facility #1, Montreal

Facility #1, Verdun

Facility #1, Québec

Facility #1, Strasbourg

Facility #1, Toulouse

Facility #1, Paris

Facility #1, Bron

Facility #1, Paris

Facility #1, Rennes

Facility #1, Villeurbanne

Facility #1, Gunzburg

Facility #1, Karlstadt am Main

Facility #1, Hanover

Facility #1, Mittweida

Facility #1, Hoppegarten

Facility #1, Berlin

Facility #2, Berlin

Facility #3, Berlin

Facility #1, Günzburg

Facility #1, Hamburg

Facility #1, Heidelberg

Facility #1, Leipzig

Facility #1, Mannheim

Facility #1, München

Facility #1, Tübingen

Facility #1, Brescia

Facility #1, Genova

Facility #1, Milan

Facility #1, Parma

Facility #1, Perugia

Facility #1, Pisa

Facility #1, Roma

Facility #2, Roma

Facility #3, Roma

Eisai Trial Site #1, Otake-shi

Eisai Trial Site #1, Himeji-shi

Eisai Trial Site #2, Himeji-shi

Eisai Trial Site #3, Himeji-shi

Eisai Trial Site #1, Kobe

Eisai Trial Site #1, Nishinomiya-shi

Eisai Trial Site #1, Kyoto

Eisai Trial Site #1, Kurashiki-shi

Eisai Trial Site #1, Osaka

Eisai Trial Site #1, Saitama-shi

Eisai Trial Site #1, Itabashi-ku

Eisai Trial Site #1, Shinjuku-ku

Eisai Trial Site #2, Shinjuku-ku

Facility #1, Amsterdam

Facility #1, Seongnam-si

Facility #1, Pusan

Facility #2, Seoul

Facility #3, Seoul

Facility #4, Seoul

Facility #1, Sant Cugat Del Vallés

Facility #1, Donostia / San Sebastian

Facility #1, Barakaldo

Facility #1, Alicante

Facility #1, Barcelona

Facility #1, Madrid

Facility #2, Madrid

Facility #1, Seville

Facility #1, Malmo

Facility #1, Mölndal

Facility #1, Stockholm

Facility #1, Uppsala

Facility #1, London

Facility #1, Isleworth

Facility #1, Glasgow

Facility #1, Bath

Facility #2, London

Facility #1, Swindon

80239-3133

Facility #1, Denver

06510

Facility #1, New Haven

Facility #2, New Haven

02115

Facility #1, Boston

02118

Facility #2, Boston

01805

Facility #1, Burlington

02459

Facility #1, Newton

48105-2945

Facility #1, Ann Arbor

07724

Facility #1, Eatontown

08755

Facility #1, Toms River

02914

Facility #1, East Providence

05201

Facility #1, Bennington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biogen

INDUSTRY

lead

Eisai Inc.

INDUSTRY