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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03036280
Registration number
NCT03036280
Ethics application status
Date submitted
3/11/2016
Date registered
6/11/2016
Date last updated
3/02/2021
Titles & IDs
Public title
A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease
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Scientific title
A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease
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Secondary ID [1]
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2016-003928-23
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Secondary ID [2]
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E2609-G000-301
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Universal Trial Number (UTN)
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Trial acronym
MissionAD1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
Core Study
* 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 or cerebrospinal fluid AD assessment or both
Extension Phase
• Participants who complete the Core Study
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Minimum age
50
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Core Study
* 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 (example, 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 (example, 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 increased risk of infection
* Have received any live vaccine/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 (QT interval with Fridericia's correction [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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/01/2020
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Sample size
Target
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Accrual to date
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Final
2212
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eisai Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.
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Trial website
https://clinicaltrials.gov/study/NCT03036280
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03036280
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