ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02956486
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
The name of this trial is MissionAD1. This 24-month treatment, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's Disease (EAD) including mild cognitive impairment (MCI) due to Alzheimer's Disease (AD)/Prodromal AD and the early stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat (proposed international nonproprietary name [INN]) (E2609).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Elenbecestat (E2609) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease
Actual Study Start Date : October 20, 2016
Estimated Primary Completion Date : March 29, 2021
Estimated Study Completion Date : March 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Elenbecestat (E2609) 50 mg
Participants will receive one 50 milligram (mg) elenbecestat (E2609) tablet orally once a day in the morning.
Drug: Elenbecestat (E2609)
tablet
Other Name: Elenbecestat

Placebo Comparator: Placebo
Participants will receive one matching placebo tablet orally once a day in the morning.
Drug: Placebo
tablet




Primary Outcome Measures :
  1. Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at 24 months [ Time Frame: Baseline; 24 months ]

Secondary Outcome Measures :
  1. Time to worsening of Clinical Dementia Rating (CDR) score by 24 months [ Time Frame: up to 24 months ]
    Worsening of the global CDR score is defined as an increase from baseline by at least 0.5 points on the global CDR scale on two consecutive scheduled visits at which global CDR is undertaken.

  2. Time to conversion to dementia by 24 months for participants who were not clinically staged as dementia at baseline based on clinical diagnosis [ Time Frame: up to 24 months ]
  3. The rate of change over time (mean slope) based on the CDR-SB score over 24 months [ Time Frame: 24 months ]
  4. Change from Baseline in CDR-SB at 27 months [ Time Frame: Baseline; 27 months (24 months of treatment plus 3 months of posttreatment follow-up) ]
  5. Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognition14 (ADAS-Cog14) score at 24 months [ Time Frame: Baseline; 24 months ]
  6. Change from Baseline in the Mini Mental State Examination (MMSE) score at 24 months [ Time Frame: Baseline; 24 months ]
  7. Change from Baseline in the Functional Assessment Questionnaire (FAQ) score at 24 months [ Time Frame: Baseline; 24 months ]
  8. Change from Baseline in the AmyloidADAS-cog14 Word List (immediate recall and delayed recall) score at 24 months [ Time Frame: Baseline; 24 months ]

Other Outcome Measures:
  1. Change from Baseline in amyloid positron emission tomography (PET) standardized uptake value ratio (SUVR) composite at 24 months for brain amyloid levels [ Time Frame: Baseline; 24 months ]
  2. Change from Baseline in cerebrospinal fluid (CSF) biomarkers t-tau and p-tau at 24 months [ Time Frame: Baseline; 24 months ]
  3. Change from Baseline in CSF amyloid biomarkers Aβ(1-42), and Aβ(1-x) at 24 months [ Time Frame: Baseline; 24 months ]
  4. Change from Baseline in total hippocampal volume at 24 months using volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline; 24 months ]
  5. Change from Baseline in the preservation of connectivity on functional magnetic resonance imaging (fMRI) at 24 months [ Time Frame: Baseline; 24 months ]
  6. Change from Baseline in tau PET Signal at 24 Months [ Time Frame: Baseline; 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild cognitive impairment due to AD or mild AD dementia including

    1. Mini Mental State Examination score equal to or greater than 24
    2. 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 PET or CSF assessment or both
  • Study partner able to support the participant for duration of the study
  • Provide written informed consent. Participants must, in the investigator's judgment, have the capacity to consent

Exclusion Criteria:

  • 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 (e.g., 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 (eg, 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 risk of increased risk of infection
  • Have received any live/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 (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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956486


Contacts
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

  Hide Study Locations
Locations
United States, Arizona
Facility #1 Not yet recruiting
Chandler, Arizona, United States, 85226
United States, Arkansas
Facility #1 Not yet recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Facility #1 Recruiting
Colton, California, United States, 92324
Facility #1 Recruiting
Costa Mesa, California, United States, 92626
Facility #1 Recruiting
Fullerton, California, United States, 92835
Facility #1 Recruiting
Imperial, California, United States, 92251
Facility #1 Recruiting
Irvine, California, United States, 92618
Facility #1 Recruiting
National City, California, United States, 91950
Facility #2 Recruiting
Oceanside, California, United States, 92054
Facility #1 Recruiting
Oceanside, California, United States, 92056
Facility #1 Recruiting
Oxnard, California, United States, 93030
Facility #1 Recruiting
Panorama City, California, United States, 91402
Facility #1 Recruiting
San Diego, California, United States, 92123
Facility #1 Not yet recruiting
San Marcos, California, United States, 92078
Facility #1 Recruiting
Yorba Linda, California, United States, 92886
United States, Colorado
Facility #1 Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Facility #1 Recruiting
Atlantis, Florida, United States, 33462
Facility #1 Recruiting
Aventura, Florida, United States, 33180
Facility #1 Recruiting
Boynton Beach, Florida, United States, 33437
Facility #1 Recruiting
Brooksville, Florida, United States, 34601
Facility #1 Recruiting
Coral Gables, Florida, United States, 33134
Facility #2 Recruiting
Coral Gables, Florida, United States, 33134
Facility #1 Recruiting
Deerfield Beach, Florida, United States, 33064
Facility #1 Recruiting
Delray Beach, Florida, United States, 33445
Facility #1 Recruiting
Doral, Florida, United States, 33122
Facility #1 Recruiting
Hialeah, Florida, United States, 33016
Facility #1 Not yet recruiting
Lake Worth, Florida, United States, 33449
Facility #1 Not yet recruiting
Melbourne, Florida, United States, 32940
Facility #1 Not yet recruiting
Merritt Island, Florida, United States, 32952
Facility #2 Recruiting
Miami, Florida, United States, 33122
Facility #9 Recruiting
Miami, Florida, United States, 33125
Facility #10 Recruiting
Miami, Florida, United States, 33126
Facility #4 Recruiting
Miami, Florida, United States, 33133
Facility #5 Recruiting
Miami, Florida, United States, 33135
Facility #1 Recruiting
Miami, Florida, United States, 33137
Facility #6 Recruiting
Miami, Florida, United States, 33144
Facility #3 Recruiting
Miami, Florida, United States, 33155
Facility #7 Recruiting
Miami, Florida, United States, 33174
Facility #8 Recruiting
Miami, Florida, United States, 33176
Facility #2 Recruiting
Orlando, Florida, United States, 32801
Facility #1 Recruiting
Orlando, Florida, United States, 32806
Facility #3 Recruiting
Orlando, Florida, United States, 32807
Facility #1 Recruiting
Palm Beach Gardens, Florida, United States, 33410
Facility #1 Recruiting
Port Charlotte, Florida, United States, 33952
Facility #1 Recruiting
Port Orange, Florida, United States, 32127
Facility #1 Recruiting
Spring Hill, Florida, United States, 34609
Facility #1 Recruiting
Tampa, Florida, United States, 33613
Facility #2 Recruiting
Tampa, Florida, United States, 33614
Facility #1 Recruiting
The Villages, Florida, United States, 32162
United States, Georgia
Facility #1 Recruiting
Atlanta, Georgia, United States, 30328
Facility #1 Recruiting
Columbus, Georgia, United States, 31909
Facility #1 Recruiting
Decatur, Georgia, United States, 30033
Facility #1 Recruiting
Suwanee, Georgia, United States, 30024
United States, Idaho
Facility #1 Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
Facility #1 Recruiting
Northbrook, Illinois, United States, 60062
Facility #1 Not yet recruiting
Springfield, Illinois, United States, 62702
United States, Kansas
Facility #1 Recruiting
Wichita, Kansas, United States, 67207
Facility #2 Not yet recruiting
Wichita, Kansas, United States, 67214
United States, Massachusetts
Facility #1 Recruiting
Boston, Massachusetts, United States, 2115
United States, Michigan
Facility #1 Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Facility #1 Recruiting
Chesterfield, Missouri, United States, 63005
Facility #1 Recruiting
O'Fallon, Missouri, United States, 63368
Facility #2 Recruiting
Saint Louis, Missouri, United States, 63104
Facility #3 Recruiting
Saint Louis, Missouri, United States, 63131
Facility #1 Recruiting
Saint Louis, Missouri, United States, 63141
Facility #1 Recruiting
Saint Peters, Missouri, United States, 63303
United States, New Jersey
Facility #1 Recruiting
Mount Arlington, New Jersey, United States, 7856
Facility #1 Not yet recruiting
Princeton, New Jersey, United States, 8540
Facility #2 Recruiting
Springfield, New Jersey, United States, 7081
Facility #1 Recruiting
Toms River, New Jersey, United States, 8755
Facility #1 Recruiting
West Long Branch, New Jersey, United States, 7764
United States, New York
Facility #1 Recruiting
Amherst, New York, United States, 14226
Facility #1 Recruiting
Brooklyn, New York, United States, 11229
Facility #1 Recruiting
New York, New York, United States, 10032
United States, Ohio
Facility #1 Recruiting
Canton, Ohio, United States, 44718
Facility #1 Recruiting
Centerville, Ohio, United States, 45459
Facility #1 Recruiting
Cleveland, Ohio, United States, 44195
Facility #1 Recruiting
Dayton, Ohio, United States, 45459
Facility #1 Recruiting
Lakewood, Ohio, United States, 44107
Facility #1 Recruiting
Westerville, Ohio, United States, 43081
United States, Oklahoma
Facility #1 Recruiting
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
Facility #1 Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Facility #1 Recruiting
Jenkintown, Pennsylvania, United States, 19046
Facility #1 Recruiting
Media, Pennsylvania, United States, 19063
Facility #1 Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Facility #1 Recruiting
East Providence, Rhode Island, United States, 2914
Facility #2 Not yet recruiting
East Providence, Rhode Island, United States
Facility #1 Recruiting
Lincoln, Rhode Island, United States, 2865
Facility #1 Recruiting
Providence, Rhode Island, United States, 2906
United States, South Carolina
Facility #1 Recruiting
Port Royal, South Carolina, United States, 29935
United States, Tennessee
Facility #1 Recruiting
Cordova, Tennessee, United States, 38018
Facility #2 Recruiting
Nashville, Tennessee, United States, 37203
Facility #1 Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Facility #1 Recruiting
Austin, Texas, United States, 78757
Facility #1 Recruiting
Dallas, Texas, United States, 75231
Facility #1 Recruiting
Houston, Texas, United States, 77084
Facility #1 Recruiting
San Antonio, Texas, United States, 78229-3900
Facility #2 Recruiting
San Antonio, Texas, United States, 78229-3900
Facility #3 Recruiting
San Antonio, Texas, United States, 78238
United States, Utah
Facility #1 Recruiting
Salt Lake City, Utah, United States, 84108
United States, Vermont
Facility #1 Recruiting
Bennington, Vermont, United States, 5201
United States, Virginia
Facility #1 Recruiting
Hampton, Virginia, United States, 23666
Facility #1 Not yet recruiting
Newport News, Virginia, United States, 23601
United States, Washington
Facility #1 Not yet recruiting
Richland, Washington, United States, 99352
United States, Wisconsin
Facility #1 Recruiting
Madison, Wisconsin, United States, 53705
Argentina
Facility #2 Recruiting
Caba, Buenos Aires, Argentina, -1405
Facility #1 Recruiting
Caba, Buenos Aires, Argentina, C1012AAR
Facility #4 Recruiting
Caba, Buenos Aires, Argentina, C1126AAB
Facility #3 Recruiting
Caba, Buenos Aires, Argentina, C1427
Facility #1 Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1111
Facility #3 Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
Facility #2 Not yet recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1230AAZ
Facility #1 Recruiting
Cordoba, Capital, Argentina, X5003DCE
Facility #1 Recruiting
Rosario, Santa Fe, Argentina, 2000
Facility #4 Recruiting
Buenos Aires, Argentina, 1199
Facility #5 Recruiting
Caba, Argentina, C1428AQK
Facility #2 Recruiting
Cordoba, Argentina, X5004A0A
Facility #3 Recruiting
Cordoba, Argentina, X5009BIN
Facility #1 Not yet recruiting
Santa Fe, Argentina, 3000
Australia, New South Wales
Facility #1 Recruiting
Darlinghurst, New South Wales, Australia, 2010
Facility #1 Recruiting
Kanwal, New South Wales, Australia
Facility #1 Recruiting
Macquarie Park, New South Wales, Australia, 2113
Facility #1 Recruiting
Tumbi Umbi, New South Wales, Australia, 2261
Australia, Queensland
Facility #1 Recruiting
Brisbane, Queensland, Australia, 4032
Australia, Victoria
Facility #1 Recruiting
Caulfield, Victoria, Australia, 3162
Facility #1 Recruiting
Geelong, Victoria, Australia, 3220
Facility #1 Recruiting
Heidelberg, Victoria, Australia, 3084
Facility #1 Recruiting
Malvern, Victoria, Australia, 3144
Facility #2 Not yet recruiting
Melbourne, Victoria, Australia
Facility #1 Recruiting
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Facility #1 Recruiting
Nedlands, Western Australia, Australia, 6009
Facility #1 Not yet recruiting
West Perth, Western Australia, Australia
Australia
Facility #3 Recruiting
Melbourne, Australia, 3146
Austria
Facility #1 Recruiting
Vienna, Austria, 1130
Facility #1 Not yet recruiting
Wien, Austria, 1090
Bulgaria
Facility #1 Not yet recruiting
Pleven, Bulgaria, 5800
Facility #1 Recruiting
Plovdiv, Bulgaria, 4002
Facility #1 Recruiting
Ruse, Bulgaria, 7002
Facility #4 Recruiting
Sofia, Bulgaria, 1142
Facility #3 Recruiting
Sofia, Bulgaria, 1309
Facility #1 Recruiting
Sofia, Bulgaria, 1431
Facility #2 Recruiting
Sofia, Bulgaria, 1431
Facility #1 Not yet recruiting
Varna, Bulgaria, 9005
Canada, British Columbia
Facility #1 Not yet recruiting
Kamloops, British Columbia, Canada, V2C 5T1
Facility #1 Recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Facility #1 Recruiting
West Vancouver, British Columbia, Canada, V7T 1C5
Canada, Nova Scotia
Facility #1 Recruiting
Halifax, Nova Scotia, Canada, B3S 1M7
Facility #1 Recruiting
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Facility #1 Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Facility #1 Recruiting
Peterborough, Ontario, Canada, K9H 2P4
Canada, Quebec
Facility #1 Recruiting
Montreal, Quebec, Canada, H1M 1B1
Facility #1 Recruiting
Sherbrooke, Quebec, Canada, J1L 0H8
Czechia
Facility #1 Recruiting
Hradec Kralove, Czechia, 500 09
Facility #1 Recruiting
Kladno, Czechia, 272 01
Facility #1 Recruiting
Olomouc, Czechia, 779 00
Facility #1 Not yet recruiting
Plzen, Czechia
Facility #2 Not yet recruiting
Plzen, Czechia
Facility #1 Recruiting
Praha 10, Czechia, 109 00
Facility #1 Recruiting
Praha 6, Czechia, 160 00
Facility #2 Not yet recruiting
Praha 6, Czechia
France
Facility #1 Recruiting
Montpellier, Herault, France, 34295
Facility #1 Recruiting
Bordeaux, France, 33076
Facility #1 Recruiting
Bron Cedex, France, 69677
Facility #1 Recruiting
Marseille Cedex 05, France, 13385
Facility #1 Recruiting
Nantes, France, 44800
Facility #1 Recruiting
Paris, France, 75013
Facility #1 Recruiting
Toulouse, France, 31059
Germany
Facility #1 Not yet recruiting
Nürnberg, Bavaria, Germany
Facility #1 Recruiting
Gunzburg, Bayern, Germany, 89312
Facility #1 Not yet recruiting
Munchen, Bayern, Germany
Facility #1 Recruiting
Neuburg, Bayern, Germany, 86633
Facility #1 Recruiting
Hoppegarten, Brandenburg, Germany, 15366
Facility #1 Recruiting
Oranienburg, Brandenburg, Germany, 16515
Facility #1 Recruiting
Frankfurt, Hessen, Germany, 60528
Facility #1 Not yet recruiting
Essen, North Rhine-Westphalia, Germany
Facility #1 Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Facility #1 Recruiting
Leipzig, Saxony, Germany, 4107
Facility #1 Recruiting
Berlin, Germany, 10245
Facility #2 Recruiting
Berlin, Germany, 10629
Facility #1 Recruiting
Gera, Germany, 7551
Facility #1 Recruiting
Homburg/Saar, Germany, 66241
Facility #1 Recruiting
Schwerin, Germany, 19053
Facility #1 Not yet recruiting
Wiesbaden, Germany
Greece
Facility #1 Not yet recruiting
Athens, Kolonaki, Greece, 11521
Facility #5 Recruiting
Athens, Greece, 11528
Facility #3 Not yet recruiting
Athens, Greece, 12462
Facility #4 Recruiting
Athens, Greece, 15123
Facility #2 Not yet recruiting
Athens, Greece, 15125
Japan
Eisai Trial Site 1 Recruiting
Anjo-shi, Aichi, Japan, 446-8510
Eisai Trial Site 1 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Eisai Trial Site 1 Recruiting
Ofu-shi, Aichi, Japan, 474-8511
Eisai Trial Site 1 Recruiting
Yoshida-gun, Fukui, Japan, 910-1193
Eisai Trial Site 1 Recruiting
Omuta-shi, Fukuoka, Japan, 837-0911
Eisai Trial Site 1 Recruiting
Fujioka-shi, Gunma, Japan, 375-0017
Eisai Trial Site 1 Recruiting
Otake-shi, Hiroshima, Japan, 739-0651
Eisai Trial Site 2 Recruiting
Himeji-shi, Hyogo, Japan, 670-0981
Eisai Trial Site 1 Recruiting
Himeji, Hyogo, Japan, 671-1227
Eisai Trial Site 1 Recruiting
Kobe, Hyogo, Japan, 650-0017
Facility #1 Not yet recruiting
Miki, Kagawa, Japan, 761-0793
Eisai Trial Site 1 Recruiting
Fujisawa-shi, Kanagawa, Japan, 251-0038
Eisai Trial Site 1 Recruiting
Kyoto-shi, Kyoto, Japan, 602-8566
Eisai Trial Site 2 Recruiting
Kyoto-shi, Kyoto, Japan, 602-8566
Eisai Trial Site 1 Recruiting
Shimogyo-ku, Kyoto, Japan
Eisai Trial Site 1 Not yet recruiting
Ise, Mie, Japan
Eisai Trial Site 1 Recruiting
Higashimorokatagun, Miyazaki, Japan, 880-1111
Eisai Trial Site 1 Not yet recruiting
Nishisonogi-gun, Nagasaki, Japan, 851-2103
Eisai Trial Site 2 Recruiting
Okayama-shi, Okayama-ken, Japan, 701-1192
Eisai Trial Site 1 Recruiting
Kurashiki-shi, Okayama, Japan, 710-0813
Eisai Trial Site 2 Recruiting
Kurashiki-shi, Okayama, Japan
Eisai Trial Site 1 Recruiting
Okayama-shi, Okayama, Japan, 700-8557
Eisai Trial Site 1 Recruiting
Hirakata, Osaka, Japan, 573-1121
Eisai Trial Site 1 Recruiting
Naniwa-Ku, Osaka, Japan, 556‐0017
Eisai Trial Site 1 Recruiting
Osaka-shi, Osaka, Japan, 534-0021
Eisai Trial Site 2 Recruiting
Osaka-shi, Osaka, Japan, 545-8586
Eisai Trial Site 3 Recruiting
Osaka-shi, Osaka, Japan
Eisai Trial Site 1 Recruiting
Suita-shi, Osaka, Japan, 565-0871
Eisai Trial Site 2 Recruiting
Suita-shi, Osaka, Japan, 565-0874
Eisai Trial Site 1 Recruiting
Suminoe-ku, Osaka, Japan, 559-0004
Eisai Trial Site 1 Recruiting
Kanzaki-gun, Saga, Japan, 842-0192
Eisai Trial Site 1 Recruiting
Otsu-shi, Shiga, Japan, 520-2192
Eisai Trial Site 2 Recruiting
Otsu, Shiga, Japan, 520-0832
Eisai Trial Site 1 Recruiting
Tokushima-shi, Tokushima, Japan, 770-8503
Eisai Trial Site 1 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-0034
Eisai Trial Site 2 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8603
Eisai Trial Site 1 Recruiting
Kodaira-shi, Tokyo, Japan, 187-8551
Eisai Trial Site 1 Recruiting
Minato-ku, Tokyo, Japan, 108-0073
Eisai Trial Site 1 Recruiting
Setagaya-ku, Tokyo, Japan, 158-8531
Eisai Trial Site 1 Recruiting
Shinjuku-ku, Tokyo, Japan, 169-0073
Eisai Trial Site 1 Recruiting
Sumida-ku, Tokyo, Japan, 130-0004
Eisai Trial Site 1 Recruiting
Hofu-shi, Yamaguchi, Japan, 747-0802
Eisai Trial Site 1 Recruiting
Kumamoto, Japan, 860-8556
Eisai Trial Site 3 Recruiting
Kyoto, Japan, 606-0851
Eisai Trial Site 4 Recruiting
Kyoto, Japan, 616-8255
Eisai Trial Site 1 Recruiting
Osaka, Japan, 553-0003
Korea, Republic of
Facility #1 Recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
Facility #1 Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 13620
Facility #1 Recruiting
Busan, Korea, Republic of, 49201
Facility #1 Recruiting
Incheon, Korea, Republic of, 22332
Facility #5 Recruiting
Seoul, Korea, Republic of, 3722
Facility #3 Recruiting
Seoul, Korea, Republic of, 4763
Facility #1 Recruiting
Seoul, Korea, Republic of, 5030
Facility #4 Recruiting
Seoul, Korea, Republic of, 6351
Facility #6 Recruiting
Seoul, Korea, Republic of, 6973
Facility #2 Recruiting
Seoul, Korea, Republic of, 7985
Poland
Facility #1 Recruiting
Katowice, Poland
Facility #1 Recruiting
Kielce, Poland, 25-411
Facility #1 Recruiting
Krakow, Poland, 30-149
Facility #1 Recruiting
Poznari, Poland, 61-853
Facility #1 Recruiting
Poznań, Poland
Facility #1 Recruiting
Siemianowice Śląskie, Poland, 41-100
Facility #1 Recruiting
Warszawa, Poland, 01-697
Romania
Facility #1 Not yet recruiting
Campulung, Arges, Romania, 115100
Facility #1 Not yet recruiting
Bucharest, District 1, Romania, 11025
Facility #1 Not yet recruiting
Caracal, Olt County, Romania, 235200
Facility #2 Not yet recruiting
Bucharest, Sector 5, Romania, 50524
Facility #3 Not yet recruiting
Bucharest, Romania, 10825
Facility #1 Not yet recruiting
Otopeni, Romania, 719513
Facility #1 Not yet recruiting
Sibiu, Romania, 550281
Serbia
Facility #1 Not yet recruiting
Belgrade, Serbia
Facility #1 Not yet recruiting
Kragujevac, Serbia
Facility #2 Not yet recruiting
Kragujevac, Serbia
Facility #1 Not yet recruiting
Novi Knezevac, Serbia
Spain
Facility #1 Recruiting
Elche, Alicante, Spain, 3203
Facility #1 Not yet recruiting
Zaragoza, Aragon, Spain, 50012
Facility #1 Recruiting
Sant Cugat Del Valles, Barcelona, Spain, 8195
Facility #1 Recruiting
Getxo, Bizkaia, Spain, 48993
Facility #1 Recruiting
Donostia/San Sebastian, Gipuzkoa, Spain, 20009
Facility #1 Recruiting
Palma de Mallorca, Illes Balears, Spain, 7120
Facility #1 Recruiting
El Palmar, Murcia, Spain, 30120
Facility #1 Not yet recruiting
Albacete, Spain, 2006
Facility #1 Recruiting
Barcelona, Spain, 8028
Facility #2 Not yet recruiting
Barcelona, Spain
Facility #2 Recruiting
Madrid, Spain, 28049
Facility #1 Recruiting
Madrid, Spain, 28223
Facility #1 Recruiting
Valencia, Spain, 46010
Facility #2 Recruiting
Valencia, Spain, 46026
Sweden
Facility #1 Not yet recruiting
Malmo, Sweden
Facility #1 Not yet recruiting
Molndal, Sweden
Facility #1 Not yet recruiting
Stockholm, Sweden
United Kingdom
Facility #1 Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB21 5EF
Facility #1 Recruiting
Chester, Cheshire, United Kingdom, CH2 1BQ
Facility #1 Recruiting
Winwick, Warrington, Cheshire, United Kingdom, WA2 8WA
Facility #1 Recruiting
Plymouth, Devon, United Kingdom, PL6 8BT
Facility #1 Recruiting
Bournemouth, Dorset, United Kingdom, BH1 4JQ
Facility #1 Recruiting
Crowborough, East Sussex, United Kingdom, TN6 1HB
Hôpital Charles Nicolle - Pavillon de l'Aubette Not yet recruiting
Rouen Cedex, France, United Kingdom, 76031
Facility #1 Recruiting
Manchester, Greater Manchester, United Kingdom, M13 9WL
Facility #1 Recruiting
Southampton, Hampshire, United Kingdom, SO30 3JB
Facility #1 Recruiting
Glasgow, Lanarkshire, United Kingdom, G20 0XA
Facility #1 Recruiting
Blackpool, Lancashire, United Kingdom, FY2 0JH
Facility #1 Recruiting
Preston, Lancashire, United Kingdom, PR2 8DW
Facility #2 Recruiting
London, Middlesex, United Kingdom, TW7 6FY
Facility #1 Recruiting
Bath, North East Somerset, United Kingdom, BA1 3NG
Facility #1 Recruiting
Northampton, Northamptonshire, United Kingdom, NN5 6UD
Facility #1 Not yet recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6AJ
Facility #1 Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Hospital Senhora da Oliveira Recruiting
Guimarães, Portugal, United Kingdom, 4835-044
Facility #1 Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZH
Psychiatrická ambulancia Recruiting
Bratislava, Slovakia, United Kingdom, 85107
Facility #1 Recruiting
Sheffield, South Yorkshire, United Kingdom, S5 7JT
Facility #1 Recruiting
Leatherhead, Surrey, United Kingdom, KT22 7AD
Facility #1 Recruiting
Dundee, Tayside, United Kingdom
Facility #1 Recruiting
Birmingham, West Midlands, United Kingdom, B168QQ
Facility #1 Recruiting
Swindon, Wilts, United Kingdom, SN3 6BW
Facility #1 Recruiting
Edinburgh, United Kingdom
Clinical Research Facility Not yet recruiting
Glasgow, United Kingdom, G31 2ER
Facility #2 Recruiting
Glasgow, United Kingdom, G51 4TF
Facility #1 Recruiting
Guildford, United Kingdom, GU2 7YD
Facility #1 Recruiting
London, United Kingdom, W1G 9RU
Facility #4 Recruiting
London, United Kingdom, W6 8RF
Facility #3 Recruiting
London, United Kingdom, WC1X 8QD
Facility #1 Recruiting
Penarth, United Kingdom
Sponsors and Collaborators
Eisai Co., Ltd.
Biogen

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02956486     History of Changes
Other Study ID Numbers: E2609-G000-301
2016-003928-23 ( EudraCT Number )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Elenbecestat
E2609
Alzheimer's Disease
Early Alzheimer's Disease
Prodromal Alzheimer's Disease
Dementia
Dementia, Alzheimer's type
Mild Cognitive Impairment
MissionAD1

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders