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

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: NCT03036280
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : June 4, 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 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

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

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 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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United States, Arizona
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Gilbert, Arizona, United States, 85234
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Phoenix, Arizona, United States, 85004
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Phoenix, Arizona, United States, 85018
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Phoenix, Arizona, United States, 85018
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Bellflower, California, United States, 90706
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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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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
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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
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Aventura, Florida, United States, 33180
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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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Maitland, Florida, United States, 32751
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Miami Springs, Florida, United States, 33166
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33126
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North Miami, Florida, United States, 33161
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Ocala, Florida, United States, 34471
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Creve Coeur, Missouri, United States, 63141
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Plains, Pennsylvania, United States, 18705
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Greenville, Texas, United States, 75401
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Houston, Texas, United States, 77074
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Mansfield, Texas, United States, 76063
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West Jordan, Utah, United States, 84088
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Richmond, Virginia, United States, 23235
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Richmond, Virginia, United States, 23294
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Middleton, Wisconsin, United States, 53562
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Praha 10, Czechia
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Praha 6, Czechia
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Rychnov nad Kneznou, Czechia
Denmark
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Vejle, Region Sonerjylland, Denmark
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Copenhagen, Denmark
Finland
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Turku, Finland
France
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Nice, France
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TOURS Cedex, France
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Villeurbanne, France
Germany
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Mannheim, Baden Wurttemberg, Germany
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Muenchen, Bavaria, Germany
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Munchen, Bayern, Germany
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Koeln, Deutschland, Germany
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Bad Homburg, Hessen, Germany
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Schwerin, Mecklenburg Vorpommern, Germany
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Westerstede, Niedersachsen, Germany
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Siegen, North Rhine-Westphalia, Germany
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Mittweida, Saxony, Germany
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Berlin, Germany
Facility #1 Not yet recruiting
Bochum, Germany
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Dusseldorf, Germany
Facility #1 Not yet recruiting
Freiburg, Germany
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Hamburg, Germany
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Ulm, Germany
Hungary
Facility #1 Recruiting
Budapest, Hungary
Facility #2 Not yet recruiting
Budapest, Hungary
Facility #1 Not yet recruiting
Komarom-Esztergom, Hungary
Israel
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Ramat Gan, HaMerkaz, Israel
Facility #1 Not yet recruiting
Zefat, Upper Galilee, Israel
Facility #1 Not yet recruiting
Holon, Israel
Facility #1 Not yet recruiting
Jerusalem, Israel
Facility #1 Not yet recruiting
Tel-Aviv, Israel
Facility #1 Not yet recruiting
Zerifin, Israel
Italy
Facility #1 Not yet recruiting
Udine, Friuli-Venezia Giulia, Italy
Facility #1 Not yet recruiting
Cefalu, Palermo, Italy
Facility #1 Not yet recruiting
Ancona, Italy
Facility #1 Not yet recruiting
Arcugnano, Italy
Facility #1 Not yet recruiting
Brescia, Italy
Facility #2 Not yet recruiting
Brescia, Italy
Facility #1 Not yet recruiting
Chieti, Italy
Facility #1 Not yet recruiting
Genova, Italy
Facility #1 Not yet recruiting
Milano, Italy
Facility #2 Not yet recruiting
Milano, Italy
Facility #3 Not yet recruiting
Milano, Italy
Facility #1 Not yet recruiting
Orbassano, Italy
Facility #1 Not yet recruiting
Pisa, Italy
Facility #1 Not yet recruiting
Pozzilli, Italy
Facility #1 Not yet recruiting
Roma, Italy
Facility #1 Not yet recruiting
Rome, Italy
Facility #2 Not yet recruiting
Rome, Italy
Facility #1 Not yet recruiting
Salerno, Italy
Facility #1 Not yet recruiting
Torino, Italy
Facility #1 Not yet recruiting
Verona, Italy
Facility #2 Not yet recruiting
Verona, Italy
Japan
Eisai Trial Site 1 Not yet recruiting
Nagoya, Aichi, Japan
Eisai Trial Site 1 Recruiting
Hirosaki, Aomori, Japan
Eisai Trial Site 1 Recruiting
Inzai, Chiba, Japan
Eisai Trial Site 1 Not yet recruiting
Urayasu, Chiba, Japan
Eisai Trial Site 1 Recruiting
Koriyama, Fukushima, Japan
Eisai Trial Site 1 Recruiting
Isesaki, Gunma, Japan
Eisai Trial Site 1 Recruiting
Maebashi, Gunma, Japan
Eisai Trial Site 1 Not yet recruiting
Sapporo, Hokkaido, Japan
Eisai Trial Site 2 Not yet recruiting
Sapporo, Hokkaido, Japan
Eisai Trial Site 3 Not yet recruiting
Sapporo, Hokkaido, Japan
Eisai Trial Site 1 Not yet recruiting
Kanazawa, Ishikawa, Japan
Eisai Trial Site 1 Recruiting
Morioka, Iwate, Japan
Eisai Trial Site 1 Recruiting
Atsugi, Kanagawa, Japan
Eisai Trial Site 1 Recruiting
Fujisawa, Kanagawa, Japan
Eisai Trial Site 1 Recruiting
Kamakura, Kanagawa, Japan
Eisai Trial Site 1 Recruiting
Kawasaki, Kanagawa, Japan
Eisai Trial Site 1 Recruiting
Yokohama, Kanagawa, Japan
Eisai Trial Site 2 Recruiting
Yokohama, Kanagawa, Japan
Eisai Trial Site 1 Recruiting
Chuo-ku, Niigata, Japan
Eisai Trial Site 1 Recruiting
Nagaoka, Niigata, Japan
Eisai Trial Site 1 Not yet recruiting
Iruma, Saitama, Japan
Eisai Trial Site 1 Not yet recruiting
Kawaguchi, Saitama, Japan
Eisai Trial Site 1 Recruiting
Koshigaya, Saitama, Japan
Eisai Trial Site 2 Recruiting
Koshigaya, Saitama, Japan
Eisai Trial Site 1 Recruiting
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 2 Recruiting
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 3 Recruiting
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Katsushika-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Koto, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Minato-ku, Tokyo, Japan
Eisai Trial Site 1 Not yet recruiting
Minato-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Mitaka-shi, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Nerima-Ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Ota, Tokyo, Japan
Eisai Trial Site 2 Not yet recruiting
Ota, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Shibuya, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Shinagawa-ku, Tokyo, Japan
Eisai Trial Site 2 Recruiting
Shinagawa-ku, Tokyo, Japan
Eisai Trial Site 1 Not yet recruiting
Shinjuku-ku, Tokyo, Japan
Eisai Trial Site 2 Recruiting
Shinjuku-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Chiba, Japan
Eisai Trial Site 2 Recruiting
Chiba, Japan
Eisai Trial Site 1 Recruiting
Shizuoka, Japan
Korea, Republic of
Facility #1 Not yet recruiting
Seongnam, Gyeonggi, Korea, Republic of
Facility #1 Not yet recruiting
Gwangju-si, Korea, Republic of
Facility #1 Not yet recruiting
Incheon, Korea, Republic of
Facility #1 Not yet recruiting
Seoul, Korea, Republic of
Facility #2 Not yet recruiting
Seoul, Korea, Republic of
Facility #3 Not yet recruiting
Seoul, Korea, Republic of
Facility #4 Not yet recruiting
Seoul, Korea, Republic of
Facility #5 Not yet recruiting
Seoul, Korea, Republic of
Facility #6 Not yet recruiting
Seoul, Korea, Republic of
Mexico
Facility #1 Not yet recruiting
Guadalajara, Jalisco, Mexico
Facility #1 Not yet recruiting
Monterrey, Nuevo Leon, Mexico
Facility #2 Not yet recruiting
Monterrey, Nuevo Leon, Mexico
Facility #3 Not yet recruiting
Monterrey, Nuevo Leon, Mexico
Facility #1 Not yet recruiting
Mexico City, Mexico
Poland
Facility #1 Recruiting
Katowice, Silesia, Poland
Facility #1 Recruiting
Bialystok, Poland
Facility #1 Recruiting
Bydgoszcz, Poland
Facility #1 Not yet recruiting
Krakow, Poland
Facility #2 Recruiting
Krakow, Poland
Facility #1 Not yet recruiting
Pruszcz Gdanski, Poland
Facility #1 Recruiting
Warszawa, Poland
Portugal
Facility #1 Not yet recruiting
Amadora, Portugal
Facility #1 Not yet recruiting
Braga, Portugal
Facility #1 Not yet recruiting
Coimbra, Portugal
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Matosinhos, Portugal
Facility #1 Not yet recruiting
Porto, Portugal
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Santa Maria da Feira, Portugal
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Torres Vedras, Portugal
Singapore
Facility #1 Not yet recruiting
Singapore, Singapore
Facility #2 Not yet recruiting
Singapore, Singapore
Slovakia
Facility #1 Not yet recruiting
Svidnik, Slovak Republic, Slovakia
Facility #1 Recruiting
Banska Bystrica, Slovakia
Facility #1 Not yet recruiting
Bratislava, Slovakia
Facility #2 Not yet recruiting
Bratislava, Slovakia
Facility #3 Not yet recruiting
Bratislava, Slovakia
Facility #1 Not yet recruiting
Dubnica nad Vahom, Slovakia
Facility #1 Not yet recruiting
Kosice, Slovakia
Facility #1 Recruiting
Rimavska Sobota, Slovakia
Facility #1 Recruiting
Roznava, Slovakia
South Africa
Facility #1 Not yet recruiting
Pinelands, Cape Town, South Africa
Facility #1 Not yet recruiting
Johannesburg, Gauteng, South Africa
Facility #1 Not yet recruiting
Cape Town, Western Cape, South Africa
Facility #1 Not yet recruiting
George, Western Cape, South Africa
Spain
Facility #2 Recruiting
Barcelona, Catalunya, Spain
Facility #1 Recruiting
San Sebastian, Gipuzkoa, Spain
Facility #1 Not yet recruiting
Getafe, Madrid, Spain
Facility #1 Not yet recruiting
Castilla Y León, Zamora, Spain
Facility #1 Recruiting
Barcelona, Spain
Facility #3 Recruiting
Barcelona, Spain
Facility #1 Not yet recruiting
Madrid, Spain
Facility #2 Not yet recruiting
Madrid, Spain
Facility #3 Not yet recruiting
Madrid, Spain
Facility #4 Not yet recruiting
Madrid, Spain
Facility #1 Not yet recruiting
Salamanca, Spain
Facility #1 Recruiting
Sevilla, Spain
Taiwan
Facility #1 Not yet recruiting
Changhua City, Changhua County, Taiwan
Facility #1 Not yet recruiting
Changhua, Taiwan
Facility #1 Not yet recruiting
Kaohsiung City, Taiwan
Facility #2 Not yet recruiting
Kaohsiung City, Taiwan
Facility #1 Not yet recruiting
New Taipei City, Taiwan
Facility #1 Not yet recruiting
Taichung City, Taiwan
Facility #2 Not yet recruiting
Tainan City, Taiwan
Facility #1 Not yet recruiting
Tainan, Taiwan
Facility #3 Not yet recruiting
Taipei City, Taiwan
Facility #1 Not yet recruiting
Taipei, Taiwan
Facility #2 Not yet recruiting
Taipei, Taiwan
Facility #1 Not yet recruiting
Taoyuan City, Taiwan
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: June 4, 2018
Last Verified: June 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