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

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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. )

November 3, 2016
November 7, 2016
September 6, 2018
October 20, 2016
March 29, 2021   (Final data collection date for primary outcome measure)
Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at 24 months [ Time Frame: Baseline; 24 months ]
Same as current
Complete list of historical versions of study NCT02956486 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
  • The rate of change over time (mean slope) based on the CDR-SB score over 24 months [ Time Frame: 24 months ]
  • 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) ]
  • Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognition14 (ADAS-Cog14) score at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in the Mini Mental State Examination (MMSE) score at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in the Functional Assessment Questionnaire (FAQ) score at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in the AmyloidADAS-cog14 Word List (immediate recall and delayed recall) score at 24 months [ Time Frame: Baseline; 24 months ]
  • 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.
  • 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 ]
  • The rate of change over time (mean slope) based on the CDR-SB score over 24 months [ Time Frame: 24 months ]
  • Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognition14 (ADAS-Cog14) score at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in the Mini Mental State Examination (MMSE) score at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in the Functional Assessment Questionnaire (FAQ) score at 24 months [ Time Frame: Baseline; 24 months ]
  • 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 ]
  • Change from Baseline in cerebrospinal fluid (CSF) biomarkers t-tau and p-tau at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in CSF amyloid biomarkers Aβ(1-42), and Aβ(1-x) at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in total hippocampal volume at 24 months using volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in the preservation of connectivity on functional magnetic resonance imaging (fMRI) at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in tau PET Signal at 24 Months [ Time Frame: Baseline; 24 months ]
  • 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 ]
  • Change from Baseline in cerebrospinal fluid (CSF) biomarkers t-tau and p-tau at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in CSF amyloid biomarkers Aβ(1-40), Aβ(1-42), and Aβ(1-x) at 24 months [ Time Frame: Baseline; 24 months ]
  • Change from Baseline in total hippocampal volume at 12 and 24 months using volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline; 12 months; 24 months ]
  • Change from Baseline in the preservation of connectivity on functional MRI (fMRI) [ Time Frame: Baseline; 12 months; 24 months ]
 
A 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Elenbecestat (E2609)
    tablet
    Other Name: Elenbecestat
  • Drug: Placebo
    tablet
  • Experimental: Elenbecestat (E2609) 50 mg
    Participants will receive one 50 milligram (mg) elenbecestat (E2609) tablet orally once a day in the morning.
    Intervention: Drug: Elenbecestat (E2609)
  • Placebo Comparator: Placebo
    Participants will receive one matching placebo tablet orally once a day in the morning.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1330
Same as current
March 29, 2021
March 29, 2021   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Older Adult)
No
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com
Argentina,   Australia,   Austria,   Bulgaria,   Canada,   Czechia,   France,   Germany,   Greece,   Japan,   Korea, Republic of,   Poland,   Romania,   Serbia,   Spain,   Sweden,   United Kingdom,   United States
Czech Republic
 
NCT02956486
E2609-G000-301
2016-003928-23 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Plan to Share IPD: Undecided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Biogen
Not Provided
Eisai Inc.
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP