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A 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease_ (MissionAD2)

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ClinicalTrials.gov Identifier: NCT03036280
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
The name of this trial is MissionAD2. 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 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 [pINN]) (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 : December 29, 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 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 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 ADAS-cog14 Word List (immediate recall and delayed recall) scores at 24 months [ Time Frame: Baseline; 24 months ]

Other Outcome Measures:
  1. Change from Baseline in amyloid positron emission tomography standardized uptake value ratio (PET 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 MRI (fMRI) at 24 months [ Time Frame: Baseline; 24 months ]


Information from the National Library of Medicine

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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 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 (PET) or cerebrospinal fluid 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 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 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): NCT03036280


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

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Locations
United States, Arizona
Facility #1 Recruiting
Gilbert, Arizona, United States, 85234
Facility #1 Recruiting
Phoenix, Arizona, United States, 85004
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Phoenix, Arizona, United States, 85018
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Phoenix, Arizona, United States, 85018
United States, Arkansas
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Little Rock, Arkansas, United States, 72209
United States, California
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Bellflower, California, United States, 90706
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Glendale, California, United States, 91204
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Irvine, California, United States, 92614
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La Jolla, California, United States
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Laguna Hills, California, United States, 92653
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Lomita, California, United States, 90717
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Long Beach, California, United States, 90822
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Los Angeles, California, United States, 90095
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Oceanside, California, United States, 92056
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Palo Alto, California, United States, 94304
CiTrials Recruiting
Riverside, California, United States, 92506
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Santa Ana, California, United States, 92704
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Santa Ana, California, United States, 92705
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Santa Monica, California, United States, 90404
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Walnut Creek, California, United States, 94598
United States, Connecticut
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New Haven, Connecticut, United States, 6510
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New London, Connecticut, United States, 6320
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Stamford, Connecticut, United States, 6901
United States, Florida
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Aventura, Florida, United States, 33180
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Bradenton, Florida, United States, 34201
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Doral, Florida, United States, 33126
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Hialeah, Florida, United States, 33012
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Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32256
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Lake Worth, Florida, United States, 33449
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Maitland, Florida, United States, 32751
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Melbourne, Florida, United States, 32940
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Miami Lakes, Florida, United States, 33014
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Miami Springs, Florida, United States, 33166
Facility #10 Recruiting
Miami, Florida, United States, 33013
Facility #2 Recruiting
Miami, Florida, United States, 33126
Facility #7 Recruiting
Miami, Florida, United States, 33126
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Miami, Florida, United States, 33135
Facility #6 Recruiting
Miami, Florida, United States, 33135
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Miami, Florida, United States, 33145
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Miami, Florida, United States, 33173
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Miami, Florida, United States, 33176
Facility #2 Recruiting
Miami, Florida, United States, 33176
Facility #8 Recruiting
Miami, Florida, United States, 33186
Facility #9 Recruiting
Miami, Florida, United States, 33186
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North Miami, Florida, United States, 33161
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Ocala, Florida, United States, 34470
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Ocala, Florida, United States, 34471
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Orange City, Florida, United States, 32763
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Orlando, Florida, United States, 32803
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Ormond Beach, Florida, United States, 32174
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Palmetto Bay, Florida, United States, 33157
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Pembroke Pines, Florida, United States, 33024
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Pinellas Park, Florida, United States, 33782
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Saint Petersburg, Florida, United States, 33709
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West Palm Beach, Florida, United States, 33407
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Decatur, Georgia, United States, 30030
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Newnan, Georgia, United States, 30265
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Chicago, Illinois, United States, 60630
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Chicago, Illinois, United States, 60640
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Elk Grove Village, Illinois, United States, 60007
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Schaumburg, Illinois, United States, 60194
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Wichita, Kansas, United States, 67207
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Baton Rouge, Louisiana, United States, 70808
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Burlington, Massachusetts, United States, 1805
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Newton, Massachusetts, United States, 2459
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Plymouth, Massachusetts, United States, 2360
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Springfield, Massachusetts, United States, 1104
United States, Mississippi
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Hattiesburg, Mississippi, United States, 39401
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Creve Coeur, Missouri, United States, 63141
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Omaha, Nebraska, United States, 68132
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Las Vegas, Nevada, United States, 89106
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Toms River, New Jersey, United States, 8755
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Toms River, New Jersey, United States, 8755
United States, New York
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Albany, New York, United States, 12208
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Glens Falls, New York, United States, 12801
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Manhasset, New York, United States, 11030
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Staten Island, New York, United States, 10312
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Woodmere, New York, United States, 11598
United States, North Carolina
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Charlotte, North Carolina, United States, 28211
Facility #2 Recruiting
Charlotte, North Carolina, United States, 28270
United States, Ohio
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Shaker Heights, Ohio, United States, 44122
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
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Medford, Oregon, United States, 97504
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Portland, Oregon, United States, 97225
United States, Pennsylvania
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Norristown, Pennsylvania, United States, 19403
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Plains, Pennsylvania, United States, 18705
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Whitehall, Pennsylvania, United States, 18104
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38119
United States, Texas
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Dallas, Texas, United States, 75231
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DeSoto, Texas, United States, 75115
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Greenville, Texas, United States, 75401
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Houston, Texas, United States, 77058
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Houston, Texas, United States, 77074
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Mansfield, Texas, United States, 76063
United States, Utah
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Salt Lake City, Utah, United States, 84107
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West Jordan, Utah, United States, 84088
United States, Virginia
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Richmond, Virginia, United States, 23235
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Richmond, Virginia, United States, 23294
United States, Wisconsin
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Middleton, Wisconsin, United States, 53562
Canada, Ontario
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Chatham, Ontario, Canada
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Toronto, Ontario, Canada, M5T 2S8
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Toronto, Ontario, Canada
Canada, Quebec
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Gatineau, Quebec, Canada, J8T 8J1
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Greenfield Park, Quebec, Canada, J4V 2J2
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Sherbrooke, Quebec, Canada, J1J 2G2
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Verdun, Quebec, Canada, H4H 1R3
Chile
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Santiago, Metropolitan Region, Chile, 6532509
Facility #2 Recruiting
Santiago, Metropolitan Region, Chile, 7500710
Facility #4 Recruiting
Santiago, Metropolitan Region, Chile, 7510186
Facility #3 Recruiting
Santiago, Metropolitan Region, Chile, 7560356
Facility #1 Recruiting
Antofagasta, Chile, 1270244
Facility #1 Not yet recruiting
Vina del Mar, Chile
China, Beijing
Facility #5 Not yet recruiting
Beijing, Beijing, China, 100029
Facility #9 Not yet recruiting
Beijing, Beijing, China, 100049
Facility #7 Not yet recruiting
Beijing, Beijing, China, 100730
Facility #8 Not yet recruiting
Beijing, Beijing, China, 100730
Facility #6 Not yet recruiting
Beijing, Beijing, China, 100853
China, Fujian
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Fuzhou, Fujian, China, 350001
China, Guangdong
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Guangzhou, Guangdong, China, 510080
Facility #2 Not yet recruiting
Guangzhou, Guangdong, China, 510120
Facility #5 Not yet recruiting
Guangzhou, Guangdong, China, 510180
Facility #4 Not yet recruiting
Guangzhou, Guangdong, China, 510260
Facility #3 Not yet recruiting
Guangzhou, Guangdong, China, 510370
China, Henan
Facility #1 Not yet recruiting
Zhengzhou, Henan, China, 450003
China, Jilin
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Changchun, Jilin, China, 130021
China, Shanghai
Facility #1 Not yet recruiting
Shanghai, Shanghai, China, 200025
Facility #3 Not yet recruiting
Shanghai, Shanghai, China, 200030
China, Shanxi
Facility #1 Not yet recruiting
Taiyuan, Shanxi, China, 30001
Facility #1 Not yet recruiting
Xi'an, Shanxi, China, 710061
China, Sichuan
Facility #1 Not yet recruiting
Chengdu, Sichuan, China, 610041
China, Tianjin
Facility #1 Not yet recruiting
Tianjin, Tianjin, China, 300222
China
Facility #2 Not yet recruiting
Beijing, China, 100050
Facility #1 Not yet recruiting
Beijing, China, 100053
Facility #4 Not yet recruiting
Beijing, China, 100083
Facility #4 Not yet recruiting
Shanghai, China, 200065
Facility #2 Not yet recruiting
Shanghai, China, 200080
Facility #5 Not yet recruiting
Shanghai, China
Facility #1 Not yet recruiting
Shenzhen, China, 518020
Croatia
Facility #1 Recruiting
Zagreb, Croatia, 10000
Facility #2 Recruiting
Zagreb, Croatia, 10000
Facility #3 Recruiting
Zagreb, Croatia, 10000
Facility #4 Not yet recruiting
Zagreb, Croatia, 10000
Facility #5 Not yet recruiting
Zagreb, Croatia, 10000
Czechia
Facility #1 Recruiting
Brno, Czechia, 60 200
Facility #2 Recruiting
Brno, Czechia, 65691
Facility #1 Not yet recruiting
Hostivice, Czechia
Facility #1 Not yet recruiting
Ostrava- Poruba, Czechia
Facility #1 Recruiting
Praha 10, Czechia, 100 00
Facility #1 Recruiting
Praha 6, Czechia, 160 00
Facility #1 Recruiting
Rychnov nad Kneznou, Czechia, 516 01
Denmark
Facility #1 Recruiting
Ballerup, Copenhagen, Denmark, 2750
Facility #1 Recruiting
Vejle, Region Sonerjylland, Denmark, 7100
Facility #1 Recruiting
Aalborg, Denmark, 9000
Facility #1 Not yet recruiting
Copenhagen, Denmark
Finland
Facility #1 Recruiting
Helsinki, Finland, 250
Facility #1 Recruiting
Kuopio, Finland, 70210
Facility #1 Recruiting
Oulu, Finland, 90220
Facility #1 Recruiting
Turku, Finland, 20250
France
Facility #1 Not yet recruiting
Aix-en-Provence, France
Facility #1 Not yet recruiting
Limoges, France, 87042
Facility #1 Recruiting
Nice, France, 6100
Facility #1 Recruiting
Paris, France, 75010
Facility #1 Recruiting
Rouen, France, 76000
Facility #1 Recruiting
TOURS Cedex, France, 37044
Facility #1 Not yet recruiting
Vienne, France, 38200
Facility #1 Not yet recruiting
Villefranche-sur-Saône, France, 69655
Facility #1 Recruiting
Villeurbanne, France, 69100
Germany
Facility #1 Recruiting
Mannheim, Baden Wurttemberg, Germany, 68159
Facility #1 Recruiting
Muenchen, Bavaria, Germany, 80336
Facility #1 Recruiting
Munchen, Bayern, Germany, 81675
Facility #1 Not yet recruiting
Koeln, Deutschland, Germany, 50937
Facility #1 Not yet recruiting
Bad Homburg, Hessen, Germany
Facility #1 Recruiting
Schwerin, Mecklenburg Vorpommern, Germany, 19055
Facility #1 Not yet recruiting
Westerstede, Niedersachsen, Germany
Facility #1 Recruiting
Siegen, North Rhine-Westphalia, Germany, 57076
Facility #1 Recruiting
Mittweida, Saxony, Germany, 9648
Facility #1 Not yet recruiting
Berlin, Germany
Facility #1 Recruiting
Bochum, Germany, 44791
Facility #1 Not yet recruiting
Dusseldorf, Germany
Facility #1 Recruiting
Freiburg, Germany, 79106
Facility #1 Recruiting
Hamburg, Germany, 20253
Facility #1 Recruiting
Ulm, Germany, 89081
Hungary
Facility #2 Recruiting
Budapest, Hungary, 1145
Facility #1 Recruiting
Budapest, Hungary, H-1083
Facility #1 Recruiting
Komarom-Esztergom, Hungary, 2500
Israel
Facility #1 Not yet recruiting
Ramat Gan, HaMerkaz, Israel, 52621
Facility #1 Not yet recruiting
Zefat, Upper Galilee, Israel, 13100
Facility #1 Not yet recruiting
Holon, Israel, 58100
Facility #1 Not yet recruiting
Jerusalem, Israel, 91240
Facility #1 Not yet recruiting
Tel-Aviv, Israel, 64239
Facility #1 Not yet recruiting
Zerifin, Israel, 70300
Italy
Facility #1 Not yet recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Facility #1 Recruiting
Cefalu, Palermo, Italy, 90015
Facility #1 Not yet recruiting
Ancona, Italy, 60127
Facility #1 Not yet recruiting
Arcugnano, Italy, 36057
Facility #1 Recruiting
Brescia, Italy, 25125
Facility #2 Not yet recruiting
Brescia, Italy
Facility #1 Recruiting
Chieti, Italy, 66100
Facility #1 Not yet recruiting
Genova, Italy, 16128
Facility #3 Recruiting
Milano, Italy, 20122
Facility #2 Recruiting
Milano, Italy, 20132
Facility #1 Recruiting
Milano, Italy, 20162
Facility #1 Recruiting
Orbassano, Italy, 10043
Facility #1 Recruiting
Pisa, Italy, 20162
Facility #1 Recruiting
Pozzilli, Italy, 86077
Facility #1 Recruiting
Roma, Italy, 189
Facility #2 Recruiting
Rome, Italy, 168
Facility #1 Recruiting
Rome, Italy, 179
Facility #1 Recruiting
Salerno, Italy, 84131
Facility #1 Recruiting
Torino, Italy, 10126
Facility #1 Recruiting
Verona, Italy, 37126
Facility #2 Recruiting
Verona, Italy
Japan
Eisai Trial Site 1 Recruiting
Nagoya, Aichi, Japan, 466-8560
Eisai Trial Site 1 Recruiting
Hirosaki-city, Aomori, Japan, 036-8563
Eisai Trial Site 2 Recruiting
Chiba-shi, Chiba, Japan, 260-8712
Eisai Trial Site 1 Recruiting
Chiba-shi, Chiba, Japan, 263-0043
Eisai Trial Site 1 Recruiting
Inzai, Chiba, Japan, 270-1694
Eisai Trial Site 1 Recruiting
Urayasu, Chiba, Japan, 279-0021
Eisai Trial Site 1 Recruiting
Koriyama, Fukushima, Japan, 968-8052
Eisai Trial Site 1 Recruiting
Isezaki-city, Gunma, Japan, 372-0006
Eisai Trial Site 1 Recruiting
Maebashi city, Gunma, Japan, 371-8511
Eisai Trial Site 3 Recruiting
Sapporo-shi, Hokkaido, Japan, 004-0004
Eisai Trial Site 2 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8543
Eisai Trial Site 1 Recruiting
Sapporo, Hokkaido, Japan, 065-0033
Eisai Trial Site 1 Recruiting
Toride, Ibaraki, Japan, 302-0004
Eisai Trial Site 1 Recruiting
Kanazawa-shi, Ishikawa, Japan, 920-8641
Eisai Trial Site 1 Recruiting
Morioka-shi, Iwate, Japan, 020-8505
Eisai Trial Site 1 Recruiting
Atsugi-shi, Kanagawa, Japan, 243-8551
Eisai Trial Site 1 Recruiting
Fujisawa-shi, Kanagawa, Japan, 251-0041
Eisai Trial Site 1 Recruiting
Kamakura-shi, Kanagawa, Japan, 247-8533
Eisai Trial Site 1 Recruiting
Kawasaki-shi, Kanagawa, Japan, 211-8533
Eisai Trial Site 1 Recruiting
Yokohama, Kanagawa, Japan, 225-0025
Eisai Trial Site 2 Recruiting
Yokohama, Kanagawa, Japan, 235-0012
Eisai Trial Site 1 Recruiting
Nagaoka, Niigata, Japan, 940-2302
Eisai Trial Site 1 Recruiting
Iruma-gun, Saitama, Japan, 350-0495
Eisai Trial Site 1 Not yet recruiting
Kasukabe City, Saitama, Japan, 344-0036
Eisai Trial Site 1 Not yet recruiting
Kawaguchi, Saitama, Japan
Eisai Trial Site 1 Recruiting
Koshigaya-shi, Saitama, Japan, 343-0032
Eisai Trial Site 2 Recruiting
Koshigaya-shi, Saitama, Japan, 343-0032
Eisai Trial Site 1 Not yet recruiting
Saitama city, Saitama, Japan, 338-8577
Eisai Trial Site 1 Recruiting
Shizuoka-city, Shizuoka, Japan, 420-8868
Eisai Trial Site 1 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Eisai Trial Site 2 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Eisai Trial Site 3 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Eisai Trial Site 4 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Eisai Trial Site 1 Recruiting
Hachioji, Tokyo, Japan, 193-0998
Eisai Trial Site 1 Recruiting
Katsushika-ku, Tokyo, Japan, 125-8506
Eisai Trial Site 1 Recruiting
Koto-ku, Tokyo, Japan, 136-0075
Eisai Trial Site 1 Recruiting
Minato-ku, Tokyo, Japan, 105-8471
Eisai Trial Site 1 Recruiting
Minato-ku, Tokyo, Japan, 108-8606
Eisai Trial Site 1 Recruiting
Mitaka City, Tokyo, Japan, 181-0013
Eisai Trial Site 1 Recruiting
Nerima-ku, Tokyo, Japan, 177-8521
Eisai Trial Site 2 Recruiting
Ota-ku, Tokyo, Japan, 143-0016
Eisai Trial Site 1 Recruiting
Ota-ku, Tokyo, Japan, 145-0065
Eisai Trial Site 1 Recruiting
Shibuya-ku, Tokyo, Japan, 150-0002
Eisai Trial Site 1 Recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Eisai Trial Site 2 Recruiting
Shinagawa-ku, Tokyo, Japan, 142-0054
Eisai Trial Site 2 Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Eisai Trial Site 1 Recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Eisai Trial Site 1 Recruiting
Chuo-ku, Japan, 950-0983
Korea, Republic of
Facility #1 Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 13620
Facility #1 Recruiting
Gwangju-si, Korea, Republic of, 61469
Facility #1 Recruiting
Incheon, Korea, Republic of, 21565
Facility #6 Recruiting
Seoul, Korea, Republic of, 3080
Facility #5 Recruiting
Seoul, Korea, Republic of, 5030
Facility #1 Recruiting
Seoul, Korea, Republic of, 5505
Facility #4 Recruiting
Seoul, Korea, Republic of, 6351
Facility #2 Recruiting
Seoul, Korea, Republic of, 6591
Facility #3 Recruiting
Seoul, Korea, Republic of, 7061
Mexico
Facility #1 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44620
Facility #1 Recruiting
Monterrey, Nuevo Leon, Mexico, 64710
Facility #2 Recruiting
Monterrey, Nuevo Leon, Mexico, 64710
Facility #3 Not yet recruiting
Monterrey, Nuevo Leon, Mexico
Facility #1 Recruiting
Mexico City, Mexico, 14260
Poland
Facility #1 Recruiting
Katowice, Silesia, Poland, 40-588
Facility #1 Recruiting
Bialystok, Poland, 15-756
Facility #1 Recruiting
Bydgoszcz, Poland, 85-065
Facility #1 Recruiting
Krakow, Poland, 31-351
Facility #2 Recruiting
Krakow, Poland, 31-505
Facility #1 Recruiting
Pruszcz Gdanski, Poland, 83-000
Facility #1 Recruiting
Warszawa, Poland, 02-507
Portugal
Facility #1 Not yet recruiting
Guimaräes, Creixomil, Portugal, 4835-044
Facility #1 Not yet recruiting
Amadora, Portugal, 2720-276
Facility #1 Recruiting
Braga, Portugal, 4710-243
Facility #1 Not yet recruiting
Coimbra, Portugal, 3000-075
Facility #1 Not yet recruiting
Matosinhos, Portugal, 4464-513 Senhora da Hora
Facility #1 Not yet recruiting
Porto, Portugal, 4099 001
Facility #1 Not yet recruiting
Santa Maria da Feira, Portugal, 4520-211
Facility #1 Recruiting
Torres Vedras, Portugal, 2560-280
Singapore
Facility #1 Recruiting
Singapore, Singapore, 119074
Facility #2 Recruiting
Singapore, Singapore, 308433
Slovakia
Facility #1 Recruiting
Svidnik, Slovak Republic, Slovakia, 089 01
Facility #1 Recruiting
Banska Bystrica, Slovakia, 974 04
Facility #2 Recruiting
Bratislava, Slovakia, 811 07
Facility #1 Recruiting
Bratislava, Slovakia, 813 69
Facility #3 Recruiting
Bratislava, Slovakia, 85107
Facility #1 Recruiting
Dubnica nad Vahom, Slovakia, 01 841
Facility #1 Recruiting
Kosice, Slovakia, 4001
Facility #1 Recruiting
Rimavska Sobota, Slovakia
Facility #1 Recruiting
Roznava, Slovakia, 04 801
South Africa
Facility #1 Recruiting
Pinelands, Cape Town, South Africa, 7405
Facility #1 Recruiting
Johannesburg, Gauteng, South Africa, 2196
Facility #2 Recruiting
Cape Town, Western Cape, South Africa, 7530
Facility #1 Recruiting
Cape Town, Western Cape, South Africa, 7551
Facility #1 Recruiting
George, Western Cape, South Africa, 6529
Spain
Facility #1 Not yet recruiting
Córdoba, Andalucia, Spain, 14011
Facility #2 Recruiting
Barcelona, Catalunya, Spain, 8025
Facility #1 Not yet recruiting
Plasencia, Cáceres - Extremadura, Spain, 10600
Facility #1 Not yet recruiting
A Coruña, Galicia, Spain, 15006
Facility #1 Recruiting
San Sebastian, Gipuzkoa, Spain, 20009
Facility #1 Recruiting
Getafe, Madrid, Spain, 28007
Facility #5 Not yet recruiting
Getafe, Madrid, Spain, 28905
Facility #1 Recruiting
Castilla Y León, Zamora, Spain, 49021
Facility #3 Recruiting
Barcelona, Spain, 8028
Facility #1 Recruiting
Barcelona, Spain, 8035
Facility #4 Recruiting
Madrid, Spain, 28040
Facility #2 Recruiting
Madrid, Spain, 28041
Facility #3 Recruiting
Madrid, Spain, 28046
Facility #1 Recruiting
Salamanca, Spain, 37003
Facility #1 Recruiting
Sevilla, Spain, 41009
Taiwan
Facility #1 Recruiting
Changhua City, Changhua County, Taiwan, 50006
Facility #1 Recruiting
Changhua, Taiwan, 50063
Facility #2 Recruiting
Kaohsiung City, Taiwan, 807
Facility #1 Not yet recruiting
Kaohsiung City, Taiwan
Facility #1 Recruiting
New Taipei City, Taiwan, 291
Facility #1 Recruiting
Taichung City, Taiwan, 404
Facility #2 Recruiting
Tainan City, Taiwan, 736
Facility #1 Not yet recruiting
Tainan, Taiwan
Facility #3 Not yet recruiting
Taipei City, Taiwan
Facility #1 Recruiting
Taipei, Taiwan, 100
Facility #2 Recruiting
Taipei, Taiwan, 112
Facility #1 Recruiting
Taiwan, Taiwan, 704
Facility #1 Recruiting
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
Eisai Co., Ltd.
Biogen

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03036280     History of Changes
Other Study ID Numbers: E2609-G000-302
2016-004128-42 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 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. ):
E2609
elenbecestat
Alzheimer's Disease
Early Alzheimer's Disease
Prodromal Alzheimer's Disease
Dementia
Dementia, Alzheimer's type
mild cognitive impairment
MissionAD2

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