A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease (MissionAD1)

January 14, 2021 updated by: Eisai Co., Ltd.

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1199
        • Facility #4
      • Caba, Argentina, C1428AQK
        • Facility #5
      • Cordoba, Argentina, X5004A0A
        • Facility #2
      • Cordoba, Argentina, X5009BIN
        • Facility #3
      • Santa Fe, Argentina, 3000
        • Facility #1
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, -1405
        • Facility #2
      • Caba, Buenos Aires, Argentina, C1012AAR
        • Facility #1
      • Caba, Buenos Aires, Argentina, C1126AAB
        • Facility #4
      • Caba, Buenos Aires, Argentina, C1427
        • Facility #3
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1111
        • Facility #1
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
        • Facility #3
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1230AAZ
        • Facility #2
    • Capital
      • Cordoba, Capital, Argentina, X5003DCE
        • Facility #1
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Facility #1
  • Australia
      • Melbourne, Australia, 3146
        • Facility #3
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Facility #1
      • Macquarie Park, New South Wales, Australia, 2113
        • Facility #1
      • Tumbi Umbi, New South Wales, Australia, 2261
        • Facility #1
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Facility #1
    • Victoria
      • Caulfield, Victoria, Australia, 3162
        • Facility #1
      • Geelong, Victoria, Australia, 3220
        • Facility #1
      • Heidelberg, Victoria, Australia, 3084
        • Facility #1
      • Malvern, Victoria, Australia, 3144
        • Facility #1
      • Melbourne, Victoria, Australia
        • Facility #2
      • Parkville, Victoria, Australia, 3050
        • Facility #1
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Facility #1
  • Austria
      • Vienna, Austria, 1130
        • Facility #1
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Facility #1
      • Plovdiv, Bulgaria, 4002
        • Facility #1
      • Ruse, Bulgaria, 7002
        • Facility #1
      • Sofia, Bulgaria, 1142
        • Facility #4
      • Sofia, Bulgaria, 1309
        • Facility #3
      • Sofia, Bulgaria, 1431
        • Facility #1
      • Sofia, Bulgaria, 1431
        • Facility #2
  • Canada
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C 5T1
        • Facility #1
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Facility #1
      • West Vancouver, British Columbia, Canada, V7T 1C5
        • Facility #1
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • Facility #1
      • Kentville, Nova Scotia, Canada, B4N 4K9
        • Facility #1
    • Ontario
      • Ottawa, Ontario, Canada, K1N 5C8
        • Facility #1
      • Peterborough, Ontario, Canada, K9H 2P4
        • Facility #1
    • Quebec
      • Montreal, Quebec, Canada, H1M 1B1
        • Facility #1
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Facility #1
  • Czechia
      • Hradec Kralove, Czechia, 500 09
        • Facility #1
      • Kladno, Czechia, 272 01
        • Facility #1
      • Olomouc, Czechia, 779 00
        • Facility #1
      • Praha 10, Czechia, 109 00
        • Facility #1
  • France
      • Bordeaux, France, 33076
        • Facility #1
      • Bron Cedex, France, 69677
        • Facility #1
      • Marseille Cedex 05, France, 13385
        • Facility #1
      • Nantes, France, 44800
        • Facility #1
      • Paris, France, 75013
        • Facility #1
      • Rouen, France, 76000
        • Facility #1
      • Toulouse, France, 31059
        • Facility #1
    • Herault
      • Montpellier, Herault, France, 34295
        • Facility #1
  • Germany
      • Berlin, Germany, 10245
        • Facility #1
      • Berlin, Germany, 10629
        • Facility #2
      • Gera, Germany, 7551
        • Facility #1
      • Homburg/Saar, Germany, 66241
        • Facility #1
      • Schwerin, Germany, 19053
        • Facility #1
    • Bayern
      • Neuburg, Bayern, Germany, 86633
        • Facility #1
    • Brandenburg
      • Hoppegarten, Brandenburg, Germany, 15366
        • Facility #1
      • Oranienburg, Brandenburg, Germany, 16515
        • Facility #1
    • Hessen
      • Frankfurt, Hessen, Germany, 60528
        • Facility #1
    • Saxony
      • Leipzig, Saxony, Germany, 4107
        • Facility #1
  • Greece
      • Athens, Greece, 11528
        • Facility #5
      • Athens, Greece, 15123
        • Facility #4
  • Japan
      • Kumamoto, Japan, 860-8556
        • Eisai trial site 1
      • Kyoto, Japan, 606-0851
        • Eisai trial site 3
      • Osaka, Japan, 553-0003
        • Eisai trial site 1
    • Aichi
      • Anjo-shi, Aichi, Japan, 446-8510
        • Eisai trial site 1
      • Nagoya-shi, Aichi, Japan, 467-8602
        • Eisai trial site 1
      • Obu-shi, Aichi, Japan, 474-8511
        • Eisai trial site 1
    • Fukui
      • Yoshida-gun, Fukui, Japan, 910-1193
        • Eisai trial site 1
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 808-0024
        • Eisai Trail Site 1
      • Omuta-shi, Fukuoka, Japan, 837-0911
        • Eisai trial site 1
    • Gunma
      • Fujioka-shi, Gunma, Japan, 375-0017
        • Eisai trial site 1
    • Hiroshima
      • Otake-shi, Hiroshima, Japan, 739-0651
        • Eisai trial site 1
    • Hyogo
      • Himeji, Hyogo, Japan, 671-1227
        • Eisai trial site 1
      • Himeji-shi, Hyogo, Japan, 670-0981
        • Eisai trial site 2
      • Kobe, Hyogo, Japan, 650-0017
        • Eisai trial site 1
    • Kagawa
      • Miki, Kagawa, Japan, 761-0793
        • Facility #1
      • Takamatsu City, Kagawa, Japan, 760-8557
        • Eisai trial site 3
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan, 251-0038
        • Eisai trial site 1
    • Kyoto
      • Kyoto City, Kyoto, Japan, 616-8255
        • Eisai Trial Site 4
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • Eisai trial site 1
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • Eisai trial site 2
      • Kyoto-shi, Kyoto, Japan, 607-8113
        • Eisai Trial Site 5
      • Shimogyo-ku, Kyoto, Japan, 600-8558
        • Eisai trial site 1
    • Miyazaki
      • Higashimorokatagun, Miyazaki, Japan, 880-1111
        • Eisai trial site 1
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 710-0813
        • Eisai trial site 1
      • Kurashiki-shi, Okayama, Japan, 710-8692
        • Eisai trial site 2
      • Okayama-shi, Okayama, Japan, 700-8557
        • Eisai trial site 1
    • Okayama-ken
      • Okayama-shi, Okayama-ken, Japan, 701-1192
        • Eisai trial site 2
    • Osaka
      • Hirakata, Osaka, Japan, 573-1121
        • Eisai trial site 1
      • Naniwa-Ku, Osaka, Japan, 556-0017
        • Eisai trial site 1
      • Osaka-shi, Osaka, Japan, 534-0021
        • Eisai trial site 1
      • Osaka-shi, Osaka, Japan, 543-8555
        • Eisai trial site 3
      • Osaka-shi, Osaka, Japan, 545-8586
        • Eisai trial site 2
      • Sakai-shi, Osaka, Japan, 593-8301
        • Eisai trial site 2
      • Suita-shi, Osaka, Japan, 565-0871
        • Eisai trial site 1
      • Suita-shi, Osaka, Japan, 565-0874
        • Eisai trial site 2
      • Suminoe-ku, Osaka, Japan, 559-0004
        • Eisai trial site 1
    • Saga
      • Kanzaki-gun, Saga, Japan, 842-0192
        • Eisai trial site 1
    • Shiga
      • Otsu, Shiga, Japan, 520-0832
        • Eisai trial site 2
      • Otsu-shi, Shiga, Japan, 520-2192
        • Eisai trial site 1
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 770-8503
        • Eisai trial site 1
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-0034
        • Eisai trial site 1
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Eisai trial site 2
      • Kodaira-shi, Tokyo, Japan, 187-8551
        • Eisai trial site 1
      • Minato-ku, Tokyo, Japan, 108-0073
        • Eisai trial site 1
      • Setagaya-ku, Tokyo, Japan, 158-8531
        • Eisai trial site 1
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • Eisai trial site 1
      • Sumida-ku, Tokyo, Japan, 130-0004
        • Eisai trial site 1
    • Yamaguchi
      • Hofu-shi, Yamaguchi, Japan, 747-0802
        • Eisai trial site 1
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Facility #1
      • Incheon, Korea, Republic of, 22332
        • Facility #1
      • Seoul, Korea, Republic of, 3722
        • Facility #5
      • Seoul, Korea, Republic of, 4763
        • Facility #3
      • Seoul, Korea, Republic of, 5030
        • Facility #1
      • Seoul, Korea, Republic of, 6351
        • Facility #4
      • Seoul, Korea, Republic of, 6973
        • Facility #6
      • Seoul, Korea, Republic of, 7985
        • Facility #2
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 13620
        • Facility #1
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
        • Facility #1
  • Poland
      • Katowice, Poland
        • Facility #1
      • Kielce, Poland, 25-411
        • Facility #1
      • Krakow, Poland, 30-149
        • Facility #1
      • Poznari, Poland, 61-853
        • Facility #1
      • Poznań, Poland
        • Facility #1
      • Siemianowice Śląskie, Poland, 41-100
        • Facility #1
      • Warszawa, Poland, 01-684
        • Facility #1
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Facility #1
  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Facility #1
  • Slovakia
      • Bratislava, Slovakia, 85107
        • Facility #1
  • Spain
      • Barcelona, Spain, 8028
        • Facility #1
      • Madrid, Spain, 28049
        • Facility #2
      • Madrid, Spain, 28223
        • Facility #1
      • Valencia, Spain, 46010
        • Facility #1
      • Valencia, Spain, 46026
        • Facility #2
    • Alicante
      • Elche, Alicante, Spain, 3203
        • Facility #1
    • Barcelona
      • Sant Cugat Del Valles, Barcelona, Spain, 8195
        • Facility #1
    • Bizkaia
      • Getxo, Bizkaia, Spain, 48993
        • Facility #1
    • Gipuzkoa
      • Donostia/San Sebastian, Gipuzkoa, Spain, 20009
        • Facility #1
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 7120
        • Facility #1
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Facility #1
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Facility #2
      • Guildford, United Kingdom, GU2 7YD
        • Facility #1
      • London, United Kingdom, W1G 9RU
        • Facility #1
      • London, United Kingdom, W6 8RF
        • Facility #4
      • London, United Kingdom, WC1X 8QD
        • Facility #3
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB21 5EF
        • Facility #1
    • Cheshire
      • Chester, Cheshire, United Kingdom, CH2 1BQ
        • Facility #1
      • Winwick, Warrington, Cheshire, United Kingdom, WA2 8WA
        • Facility #1
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8BT
        • Facility #1
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH1 4JQ
        • Facility #1
    • East Sussex
      • Crowborough, East Sussex, United Kingdom, TN6 1HB
        • Facility #1
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Facility #1
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO30 3JB
        • Facility #1
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G20 0XA
        • Facility #1
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY2 0JH
        • Facility #1
      • Preston, Lancashire, United Kingdom, PR2 8DW
        • Facility #1
    • Middlesex
      • London, Middlesex, United Kingdom, TW7 6FY
        • Facility #2
    • North East Somerset
      • Bath, North East Somerset, United Kingdom, BA1 3NG
        • Facility #1
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Facility #1
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZH
        • Facility #1
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S5 7JT
        • Facility #1
    • Surrey
      • Leatherhead, Surrey, United Kingdom, KT22 7AD
        • Facility #1
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B168QQ
        • Facility #1
    • Wilts
      • Swindon, Wilts, United Kingdom, SN3 6BW
        • Facility #1
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Facility #1
    • California
      • Colton, California, United States, 92324
        • Facility #1
      • Costa Mesa, California, United States, 92626
        • Facility #1
      • Fullerton, California, United States, 92835
        • Facility #1
      • Imperial, California, United States, 92251
        • Facility #1
      • Irvine, California, United States, 92618
        • Facility #1
      • Lemon Grove, California, United States, 91945
        • Facility #1
      • Oceanside, California, United States, 92054
        • Facility #1
      • Oceanside, California, United States, 92054
        • Facility #2
      • Oxnard, California, United States, 93030
        • Facility #1
      • Panorama City, California, United States, 91402
        • Facility #1
      • San Diego, California, United States, 92123
        • Facility #1
    • Colorado
      • Denver, Colorado, United States, 80218
        • Facility #1
    • Florida
      • Atlantis, Florida, United States, 33462
        • Facility #1
      • Aventura, Florida, United States, 33187
        • Facility #1
      • Aventura, Florida, United States, 33187
        • Facility #2
      • Boynton Beach, Florida, United States, 33437
        • Facility #1
      • Coral Gables, Florida, United States, 33134
        • Facility #1
      • Coral Gables, Florida, United States, 33134
        • Facility #2
      • Delray Beach, Florida, United States, 33445
        • Facility #1
      • Doral, Florida, United States, 33122
        • Facility #1
      • Hialeah, Florida, United States, 33016
        • Facility #1
      • Miami, Florida, United States, 33137
        • Facility #1
      • Miami, Florida, United States, 33122
        • Facility #2
      • Miami, Florida, United States, 33125
        • Facility #11
      • Miami, Florida, United States, 33125
        • Facility #9
      • Miami, Florida, United States, 33126
        • Facility #10
      • Miami, Florida, United States, 33133
        • Facility #4
      • Miami, Florida, United States, 33144
        • Facility #6
      • Miami, Florida, United States, 33155
        • Facility #3
      • Miami, Florida, United States, 33174
        • Facility #7
      • Miami, Florida, United States, 33176
        • Facility #8
      • Orlando, Florida, United States, 32806
        • Facility #1
      • Orlando, Florida, United States, 32801
        • Facility #2
      • Orlando, Florida, United States, 32807
        • Facility #3
      • Palm Beach Gardens, Florida, United States, 33410
        • Facility #1
      • Pompano Beach, Florida, United States, 33064
        • Facility #1
      • Port Charlotte, Florida, United States, 33952
        • Facility #1
      • Port Orange, Florida, United States, 32127
        • Facility #1
      • Spring Hill, Florida, United States, 34609
        • Facility #1
      • Tampa, Florida, United States, 33613
        • Facility #1
      • Tampa, Florida, United States, 33614
        • Facility #2
      • The Villages, Florida, United States, 32162
        • Facility #1
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Facility #1
      • Columbus, Georgia, United States, 31909
        • Facility #1
      • Decatur, Georgia, United States, 30033
        • Facility #1
      • Suwanee, Georgia, United States, 30024
        • Facility #1
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Facility #1
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Facility #1
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Facility #2
    • Massachusetts
      • Boston, Massachusetts, United States, 2115
        • Facility #1
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Facility #1
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Facility #1
      • O'Fallon, Missouri, United States, 63368
        • Facility #1
      • Saint Louis, Missouri, United States, 63104
        • Facility #2
      • Saint Peters, Missouri, United States, 63303
        • Facility #1
    • New Jersey
      • Mount Arlington, New Jersey, United States, 7856
        • Facility #1
      • Springfield, New Jersey, United States, 7081
        • Facility #2
      • West Long Branch, New Jersey, United States, 7764
        • Facility #1
    • New York
      • Amherst, New York, United States, 14226
        • Facility #1
      • Brooklyn, New York, United States, 11229
        • Facility #1
      • New York, New York, United States, 10032
        • Facility #1
    • Ohio
      • Canton, Ohio, United States, 44718
        • Facility #1
      • Centerville, Ohio, United States, 45459
        • Facility #1
      • Cleveland, Ohio, United States, 44195
        • Facility #1
      • Dayton, Ohio, United States, 45459
        • Facility #1
      • Lakewood, Ohio, United States, 44107
        • Facility #1
      • Westerville, Ohio, United States, 43081
        • Facility #1
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Facility #1
    • Oregon
      • Portland, Oregon, United States, 97210
        • Facility #1
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Facility #1
      • Media, Pennsylvania, United States, 19063
        • Facility #1
      • Philadelphia, Pennsylvania, United States, 19104
        • Facility #1
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Facility #1
      • Providence, Rhode Island, United States, 2906
        • Facility #1
    • South Carolina
      • Port Royal, South Carolina, United States, 29935
        • Facility #1
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Facility #1
      • Nashville, Tennessee, United States, 37203
        • Facility #2
      • Nashville, Tennessee, United States, 37212
        • Facility #1
    • Texas
      • Austin, Texas, United States, 78757
        • Facility #1
      • Dallas, Texas, United States, 75231
        • Facility #1
      • Houston, Texas, United States, 77084
        • Facility #1
      • San Antonio, Texas, United States, 78229-3900
        • Facility #1
      • San Antonio, Texas, United States, 78240
        • Facility #3
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Facility #1
    • Vermont
      • Bennington, Vermont, United States, 5201
        • Facility #1
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Facility #1
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Facility #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Core Study

  • Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including

    1. Mini Mental State Examination score equal to or greater than 24
    2. Clinical Dementia Rating (CDR) global score of 0.5
    3. CDR Memory Box score of 0.5 or greater
  • Impaired episodic memory confirmed by a list learning task
  • Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography or cerebrospinal fluid AD assessment or both

Extension Phase

• Participants who complete the Core Study

Exclusion Criteria:

Core Study

  • Females who are breastfeeding or pregnant at Screening or Baseline. Females of child-bearing potential must use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation
  • Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
  • Participants with a history of seizures within 5 years of Screening
  • History of transient ischemic attacks or stroke within 12 months of Screening
  • Psychiatric diagnosis or symptoms (example, hallucinations, major depression, delusions etc.)
  • Suicidal ideation or any suicidal behavior within 6 months before Screening or has been hospitalized or treated for suicidal behavior in the past 5 years

  • Have any contraindications to magnetic resonance imaging (MRI) scanning or

    1. Have lesions that could indicate a dementia diagnosis other than AD on brain MRI
    2. Exhibit other significant pathological findings on brain MRI.
  • Participants who have a history of moderate to severe hepatic impairment (example, Child-Pugh Class B or C)

  • Results of laboratory tests conducted during Screening that are outside the following limits:

    1. Absolute lymphocyte count below the lower limit of normal (LLN)
    2. Thyroid stimulating hormone above normal range
    3. Abnormally low Vitamin B12 levels
  • Participants at increased risk of infection
  • Have received any live vaccine/live attenuated vaccine in the 3 months before randomization
  • Any chronic inflammatory disease that is not adequately controlled or that requires systemic immunosuppressive or immunomodulatory therapy
  • Any other clinically significant abnormalities
  • Severe visual or hearing impairment
  • A prolonged corrected QT (QTc) interval (QT interval with Fridericia's correction [QTcF] greater than 450 milliseconds [ms])
  • Malignant neoplasms within 5 years of Screening
  • Known or suspected history of drug or alcohol abuse
  • Taking prohibited medications, which must be reviewed with the Investigator
  • Have participated in a recent clinical study

Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Core Study: Elenbecestat 50 mg
Participants will receive one 50 milligram (mg) elenbecestat tablet, orally, once a day in the morning. The core study will be double blinded.
Drug: Elenbecestat
Oral tablet.
Other Names:
  • E2609
Placebo Comparator: Core Study: Placebo
Participants will receive one matching placebo tablet, orally, once a day in the morning. The core study will be double blinded.
Drug: Placebo
Oral tablet.
Experimental: Open-label Extension Phase: Elenbecestat 50 mg
Participants completing the core study will receive one 50 mg elenbecestat tablet, orally, once a day in the morning.
Drug: Elenbecestat
Oral tablet.
Other Names:
  • E2609

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
The clinical dementia rating (CDR) scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase
A TEAE is defined as an adverse event that emerged during treatment or within 28 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened 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 safety assessments of laboratory tests, suicidal ideation and suicidal behavior, drug abuse potential, physical examination, neurological examination, regular measurement of vital signs, magnetic resonance imaging and electrocardiogram parameter values.
From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), the Mini Mental State Examination (MMSE), and the CDR. Four items are from the ADAS-cog (A4 [Delayed Word Recall], A7 [Orientation], A8 [Word Recognition], A11 [Word Finding]); 2 items are from the MMSE (M1 [Orientation Time], M7 [Drawing]); 6 items are from the CDR (C1 [Personal Care], C2 [Community Affairs], C3 [Home and Hobbies], C4 [Judgment and Problem Solving], C5 [Memory], C6 [Orientation]). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score indicates worse performance.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Amyloid PET scan assesses cerebral amyloid load using 3 tracers (florbetapir, florbetaben and flutemetamol) which is standardized into centiloids for evaluation of AD. Centiloid values on centiloid scale is based on mean composite SUVR in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the CDR-SB Score for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment. Amyloid PET scans allow in vivo assessment of cerebral amyloid load. SUVR indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the ADAS-cog, the MMSE, and the CDR. Four items are from the ADAS-cog (A4 [Delayed Word Recall], A7 [Orientation], A8 [Word Recognition], A11 [Word Finding]); 2 items are from the MMSE (M1 [Orientation Time], M7 [Drawing]); 6 items are from the CDR (C1 [Personal Care], C2 [Community Affairs], C3 [Home and Hobbies], C4 [Judgment and Problem Solving], C5 [Memory], C6 [Orientation]). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score indicates worse performance. Amyloid PET scans allow in vivo assessment of cerebral amyloid load. SUVR indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24
Time Frame: Up to Month 24 of the core phase
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment. In this outcome measure, change per year (mean slope) in CDR-SB score was calculated up to month 24, where higher change indicated more impairment and lower change indicated less impairment.
Up to Month 24 of the core phase
Core Phase: Time to Worsening of CDR Score up to Month 24
Time Frame: Up to Month 24 of the core phase
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The global CDR score is computed via an algorithm and ranges from 0 to 3. Higher score indicates more impairment. In this outcome measure, time (in months) to worsening of CDR score (that is, an increase from baseline by at least 0.5 points on the global CDR scale on 2 consecutive scheduled visits) up to month 24 was calculated.
Up to Month 24 of the core phase
Core Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 24
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Time (in months) to conversion to dementia for participants who were not clinically staged as having dementia at the core phase baseline (that is time from randomization to conversion to dementia in clinical diagnosis).
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition14 (ADAS-Cog14) Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall [0-10], Commands [0-5], Constructional Praxis [0-5], Delayed Word-recall [0-10], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5], Executive Function [0-5], and Number Cancellation [0-5] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The total score ranges from 0 to 90. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the MMSE Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
The MMSE is a cognitive instrument commonly used for screening purposes, for staging of disease severity and is often measured longitudinally in AD clinical studies to follow disease progression and treatment effects. MMSE is composed of 30 questions grouped into domains (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Naming [0-2], Repetition [0-1], Comprehension [0-3], Reading [0-1], Writing [0-1], Drawing [0-1]). For each of the MMSE domains, six items are computed (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Language: Naming, Repetition, Comprehension, Reading, Writing, and Drawing [0-9]). The MMSE Total Score is the sum of the six domains and ranges from 0 to 30. If any domain score was missing then the total score was missing. Higher score indicates better function.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the Functional Assessment Questionnaire (FAQ) Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
FAQ scores 10 items & measures activities of daily living (paying bills/balancing checkbook, assembling tax records, shopping alone for clothes or groceries, playing game of skill such as bridge or chess/working on a hobby, heating water & turning off stove, preparing balanced meal, keeping track of current events, paying attention & understanding television program, remembering appointments, driving or traveling out of neighborhood). Each item is rated as follows: 0=Normal, 1=Has difficulty but does by self, 2=Requires assistance, 3=Dependent, or 8=Not Applicable. The total score is the sum of all 10 items & ranges from 0 to 30. Higher score indicates more impairment. If any activity was missed, then the total score was missed. Activities rated as "Not Applicable" were not used in the computation of the total score. To account for "Not Applicable" activity, the total score was weighted as:Total Score=Total Score*30/(30 minus 3 times the number of activities marked"Not Applicable").
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
The ADAS-cog14 Word List is a summation of two items: "Immediate Word-recall" and "Delayed Word-recall". Immediate Word-recall test: Participants are asked to recall words and the number of "No" responses for each trial (total 3 trials) are summed. Subscore: sum of scores from 3 trials, divided by 3. Score ranges from 0 to 10. Delayed Word-recall: Participants used to recall words after a delay and the number of "No" responses are summed. Score ranges from 0 to 10. The Total Score ranges from 0 to 20. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition11 (ADAS-Cog11) Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
ADAS-cog11 is a psychometric instrument that evaluates 11-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5] test) and is considered more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The Total score ranges from 0 to 70. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Core Phase: Change From Last Dose in the CDR-SB Score
Time Frame: From last dose in the core phase (up to Month 24) up to 3 months follow up (up to Month 27)
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment.
From last dose in the core phase (up to Month 24) up to 3 months follow up (up to Month 27)
Core Phase: Change From Last Dose in the ADCOMS
Time Frame: From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the ADAS-cog, the MMSE, and the CDR. Four items are from the ADAS-cog (A4 [Delayed Word Recall], A7 [Orientation], A8 [Word Recognition], A11 [Word Finding]); 2 items are from the MMSE (M1 [Orientation Time], M7 [Drawing]); 6 items are from the CDR (C1 [Personal Care], C2 [Community Affairs], C3 [Home and Hobbies], C4 [Judgment and Problem Solving], C5 [Memory], C6 [Orientation]). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score indicates worse performance.
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Core Phase: Change From Last Dose in the ADAS-cog11 Score
Time Frame: From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
ADAS-cog11 is a psychometric instrument that evaluates 11-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5] test) and is considered more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The Total score ranges from 0 to 70. Higher score indicates more impairment.
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Core Phase: Change From Last Dose in the ADAS-cog14 Score
Time Frame: From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Delayed Word-recall [0-10], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5], Executive Function [0-5], and Number Cancellation [0-5] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The Total Score ranges from 0 to 90. Higher score indicates more impairment.
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Core Phase: Change From Last Dose in the MMSE Score
Time Frame: From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
The MMSE is a cognitive instrument commonly used for screening purposes, for staging of disease severity and is often measured longitudinally in AD clinical studies to follow disease progression and treatment effects. MMSE is composed of 30 questions grouped into domains (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Naming [0-2], Repetition [0-1], Comprehension [0-3], Reading [0-1], Writing [0-1], Drawing [0-1]). For each of the MMSE domains, six items are computed (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Language: Naming, Repetition, Comprehension, Reading, Writing, and Drawing [0-9]). The MMSE Total Score is the sum of the six domains and ranges from 0 to 30. If any domain score was missing then the total score was missing. Higher score indicates better function.
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Core Phase: Change From Last Dose in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score
Time Frame: From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
The ADAS-cog14 Word List is a summation of two items: "Immediate Word-recall" and "Delayed Word-recall". Immediate Word-recall test: Participants are asked to recall words and the number of "No" responses for each trial (total 3 trials) are summed. Subscore: sum of scores from 3 trials, divided by 3. Score ranges from 0 to 10. Delayed Word-recall: Participants used to recall words after a delay and the number of "No" responses are summed. Score ranges from 0 to 10. The Total Score ranges from 0 to 20. Higher score indicates more impairment.
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in CDR-SB Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADCOMS
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the ADAS-cog, the MMSE, and the CDR. Four items are from the ADAS-cog (A4 [Delayed Word Recall], A7 [Orientation], A8 [Word Recognition], A11 [Word Finding]); 2 items are from the MMSE (M1 [Orientation Time], M7 [Drawing]); 6 items are from the CDR (C1 [Personal Care], C2 [Community Affairs], C3 [Home and Hobbies], C4 [Judgment and Problem Solving], C5 [Memory], C6 [Orientation]). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score indicates worse performance.
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in MMSE Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
The MMSE is a cognitive instrument commonly used for screening purposes, for staging of disease severity and is often measured longitudinally in AD clinical studies to follow disease progression and treatment effects. MMSE is composed of 30 questions grouped into domains (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Naming [0-2], Repetition [0-1], Comprehension [0-3], Reading [0-1], Writing [0-1], Drawing [0-1]). For each of the MMSE domains, six items are computed (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Language: Naming, Repetition, Comprehension, Reading, Writing, and Drawing [0-9]). The MMSE Total Score is the sum of the six domains and ranges from 0 to 30. If any domain score is missing then the total score is missing. Higher score indicates better function.
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in FAQ Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
FAQ scores 10 items & measures activities of daily living (paying bills/balancing checkbook, assembling tax records, shopping alone for clothes or groceries, playing game of skill such as bridge or chess/working on a hobby, heating water & turning off stove, preparing balanced meal, keeping track of current events, paying attention & understanding television program, remembering appointments, driving or traveling out of neighborhood). Each item is rated as follows: 0=Normal, 1=Has difficulty but does by self, 2=Requires assistance, 3=Dependent, or 8=Not Applicable. The total score is the sum of all 10 items & ranges from 0 to 30. Higher score indicates more impairment. If any activity was missed, then the total score was missed. Activities rated as "Not Applicable" were not used in the computation of the total score. To account for "Not Applicable" activity, the total score was weighted as:Total Score=Total Score*30/(30 minus 3 times the number of activities marked"Not Applicable").
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Delayed Word-recall [0-10], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5], Executive Function [0-5], and Number Cancellation [0-5] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The total score ranges from 0 to 90. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
The ADAS-cog14 Word List is a summation of two items: "Immediate Word-recall" and "Delayed Word-recall". Immediate Word-recall test: Participants are asked to recall words and the number of "No" responses for each trial (total 3 trials) are summed. Subscore: sum of scores from 3 trials, divided by 3. Score ranges from 0 to 10. Delayed Word-recall: Participants used to recall words after a delay and the number of "No" responses are summed. Score ranges from 0 to 10. The Total Score ranges from 0 to 20. Higher score indicates more impairment.
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Extension Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 12 of the Extension Phase
Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Time (in months) to conversion to dementia for participants who were not clinically staged as having dementia at the core phase baseline (that is time from randomization to conversion to dementia in clinical diagnosis).
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Collaborators

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2016

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2609-G000-301
  • 2016-003928-23 (EudraCT Number)
  • 2016-004128-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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