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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 : June 4, 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 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 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 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 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): NCT02956486


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

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United States, Arkansas
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Little Rock, Arkansas, United States, 72205
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Costa Mesa, California, United States, 92626
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Fullerton, California, United States, 92835
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Irvine, California, United States, 92618
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National City, California, United States, 91950
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Oceanside, California, United States, 92056
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Atlantis, Florida, United States, 33462
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Salt Lake City, Utah, United States, 84108
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Newport News, Virginia, United States, 23601
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Richland, Washington, United States, 99352
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Madison, Wisconsin, United States, 53705
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Australia
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Melbourne, Australia
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Varna, Bulgaria
Canada, British Columbia
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Kelowna, British Columbia, Canada
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Sherbrooke, Quebec, Canada
Czechia
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Hradec Kralove, Czechia
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Kladno, Czechia
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Plzen, Czechia
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Praha 10, Czechia
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Praha 6, Czechia
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Praha 6, Czechia
France
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Montpellier, Herault, France
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Bordeaux, France
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Bron Cedex, France
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Marseille Cedex 05, France
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Nantes, France
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Paris, France
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Toulouse, France
Germany
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Nurnberg, Bavaria, Germany
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Gunzburg, Bayern, Germany
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Munchen, Bayern, Germany
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Neuburg, Bayern, Germany
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Hoppegarten, Brandenburg, Germany
Facility #1 Not yet recruiting
Oranienburg, Brandenburg, Germany
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Frankfurt, Hessen, Germany
Facility #1 Not yet recruiting
Essen, North Rhine-Westphalia, Germany
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Berlin, Germany
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Gera, Germany
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Homburg, Germany
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Wiesbaden, Germany
Greece
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Athens, Kolonaki, Greece
Facility #2 Not yet recruiting
Athens, Greece
Facility #3 Not yet recruiting
Athens, Greece
Facility #4 Not yet recruiting
Athens, Greece
Facility #5 Not yet recruiting
Athens, Greece
Japan
Eisai Trial Site 1 Recruiting
Anjo, Aichi, Japan
Eisai Trial Site 1 Recruiting
Nagoya-shi, Aichi, Japan
Eisai Trial Site 1 Recruiting
Ofu, Aichi, Japan
Eisai Trial Site 1 Recruiting
Yoshida, Fukui, Japan
Eisai Trial Site 1 Recruiting
Omuta, Fukuoka, Japan
Eisai Trial Site 1 Recruiting
Fujioka, Gunma, Japan
Eisai Trial Site 1 Recruiting
Otake, Hiroshima, Japan
Eisai Trial Site 1 Recruiting
Himeji, Hyogo, Japan
Eisai Trial Site 2 Recruiting
Himeji, Hyogo, Japan
Eisai Trial Site 1 Recruiting
Kobe, Hyogo, Japan
Eisai Trial Site 1 Recruiting
Fujisawa, Kanagawa, Japan
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
Eisai Trial Site 1 Not yet recruiting
Nishisonogigun, Nagasaki, Japan
Eisai Trial Site 2 Recruiting
Okayama, Okayama-ken, Japan
Eisai Trial Site 1 Recruiting
Kurashiki, Okayama, Japan
Eisai Trial Site 2 Recruiting
Kurashiki, Okayama, Japan
Eisai Trial Site 1 Recruiting
Hirakata, Osaka, Japan
Eisai Trial Site 1 Recruiting
Naniwa-Ku, Osaka, Japan
Eisai Trial Site 1 Recruiting
Osaka-shi, Osaka, Japan
Eisai Trial Site 2 Recruiting
Osaka-shi, Osaka, Japan
Eisai Trial Site 3 Recruiting
Osaka-shi, Osaka, Japan
Eisai Trial Site 1 Recruiting
Suita, Osaka, Japan
Eisai Trial Site 2 Recruiting
Suita, Osaka, Japan
Eisai Trial Site 1 Recruiting
Suminoe-ku, Osaka, Japan
Eisai Trial Site 1 Recruiting
Kanzaki, Saga, Japan
Eisai Trial Site 1 Recruiting
Otsu, Shiga, Japan
Eisai Trial Site 2 Not yet recruiting
Otsu, Shiga, Japan
Eisai Trial Site 1 Recruiting
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 2 Recruiting
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Kodaira, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Minato-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Setagaya-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Shinjuku-ku, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Sumida, Tokyo, Japan
Eisai Trial Site 1 Recruiting
Hofu, Yamaguchi, Japan
Eisai Trial Site 1 Recruiting
Kumamoto, Japan
Eisai Trial Site 1 Recruiting
Kyoto, Japan
Eisai Trial Site 2 Recruiting
Kyoto, Japan
Eisai Trial Site 3 Recruiting
Kyoto, Japan
Eisai Trial Site 4 Not yet recruiting
Kyoto, Japan
Eisai Trial Site 1 Recruiting
Okayama, Japan
Eisai Trial Site 1 Recruiting
Osaka, Japan
Eisai Trial Site 1 Recruiting
Tokushima, Japan
Korea, Republic of
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Bucheon-si, Gyeonggi-do, Korea, Republic of
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Seongnam, Gyeonggi, Korea, Republic of
Facility #1 Recruiting
Busan, Korea, Republic of
Facility #1 Recruiting
Incheon, Korea, Republic of
Facility #1 Recruiting
Seoul, Korea, Republic of
Facility #2 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 Recruiting
Seoul, Korea, Republic of
Facility #6 Not yet recruiting
Seoul, Korea, Republic of
Poland
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Katowice, Poland
Facility #1 Recruiting
Kielce, Poland
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Krakow, Poland
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Poznan, Poland
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Warszawa, Poland
Romania
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Campulung, Arges, Romania
Facility #1 Not yet recruiting
Bucharest, District 1, Romania
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Caracal, Olt County, Romania
Facility #2 Not yet recruiting
Bucharest, Sector 5, Romania
Facility #3 Not yet recruiting
Bucharest, Romania
Facility #1 Not yet recruiting
Otopeni, Romania
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Sibiu, Romania
Serbia
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Belgrade, Serbia
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Kragujevac, Serbia
Facility #2 Not yet recruiting
Kragujevac, Serbia
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Novi Knezevac, Serbia
Spain
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Elche, Alicante, Spain
Facility #1 Recruiting
Sant Cugat Del Valles, Barcelona, Spain
Facility #1 Recruiting
Getxo, Bizkaia, Spain
Facility #1 Recruiting
Donostia/San Sebastian, Gipuzkoa, Spain
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Palma de Mallorca, Illes Balears, Spain
Facility #1 Not yet recruiting
El Palmar, Murcia, Spain
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Barcelona, Spain
Facility #2 Not yet recruiting
Barcelona, Spain
Facility #1 Recruiting
Madrid, Spain
Facility #2 Not yet recruiting
Madrid, Spain
Facility #1 Recruiting
Valencia, Spain
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Valencia, Spain
Sweden
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Malmo, Sweden
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Molndal, Sweden
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Stockholm, Sweden
United Kingdom
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Cambridge, Cambridgeshire, United Kingdom
Facility #1 Not yet recruiting
Chester, Cheshire, United Kingdom
Facility #1 Not yet recruiting
Warrington, Cheshire, United Kingdom
Facility #1 Recruiting
Plymouth, Devon, United Kingdom
Facility #1 Not yet recruiting
Bournemouth, Dorset, United Kingdom
Facility #1 Recruiting
Crowborough, East Sussex, United Kingdom
Facility #1 Not yet recruiting
Manchester, Greater Manchester, United Kingdom
Facility #1 Recruiting
Southampton, Hampshire, United Kingdom
Facility #1 Recruiting
Glasgow, Lanarkshire, United Kingdom
Facility #1 Recruiting
Blackpool, Lancashire, United Kingdom
Facility #1 Recruiting
Preston, Lancashire, United Kingdom
Facility #2 Not yet recruiting
London, Middlesex, United Kingdom
Facility #1 Recruiting
Bath, North East Somerset, United Kingdom
Facility #1 Not yet recruiting
Northampton, Northamptonshire, United Kingdom
Facility #1 Not yet recruiting
Belfast, Northern Ireland, United Kingdom
Facility #1 Recruiting
Oxford, Oxfordshire, United Kingdom
Facility #1 Recruiting
Aberdeen, Scotland, United Kingdom
Facility #1 Not yet recruiting
Sheffield, South Yorkshire, United Kingdom
Facility #1 Not yet recruiting
Leatherhead, Surrey, United Kingdom
Facility #1 Not yet recruiting
Dundee, Tayside, United Kingdom
Facility #1 Recruiting
Birmingham, West Midlands, United Kingdom
Facility #1 Recruiting
Swindon, Wilts, United Kingdom
Facility #1 Not yet recruiting
Edinburgh, United Kingdom
Facility #2 Recruiting
Glasgow, United Kingdom
Facility #1 Recruiting
Guildford, United Kingdom
Facility #1 Recruiting
London, United Kingdom
Facility #3 Recruiting
London, United Kingdom
Facility #4 Not yet recruiting
London, United Kingdom
Facility #1 Not yet 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: 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. ):
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