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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02956486




Registration number
NCT02956486
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
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
Secondary ID [1] 0 0
2016-003928-23
Secondary ID [2] 0 0
E2609-G000-301
Universal Trial Number (UTN)
Trial acronym
MissionAD1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Elenbecestat
Treatment: Drugs - Placebo

Experimental: Core Study: Elenbecestat 50 mg - Participants will receive one 50 milligram (mg) elenbecestat tablet, orally, once a day in the morning. The core study will be double blinded.

Placebo comparator: Core Study: Placebo - Participants will receive one matching placebo tablet, orally, once a day in the morning. The core study will be double blinded.

Experimental: Open-label Extension Phase: Elenbecestat 50 mg - Participants completing the core study will receive one 50 mg elenbecestat tablet, orally, once a day in the morning.


Treatment: Drugs: Elenbecestat
Oral tablet.

Treatment: Drugs: Placebo
Oral tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score
Timepoint [1] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Primary outcome [2] 0 0
Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase
Secondary outcome [1] 0 0
Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)
Timepoint [1] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [2] 0 0
Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)
Timepoint [2] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [3] 0 0
Core Phase: Change From Baseline up to Month 24 in the CDR-SB Score for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6
Timepoint [3] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [4] 0 0
Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6
Timepoint [4] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [5] 0 0
Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24
Timepoint [5] 0 0
Up to Month 24 of the core phase
Secondary outcome [6] 0 0
Core Phase: Time to Worsening of CDR Score up to Month 24
Timepoint [6] 0 0
Up to Month 24 of the core phase
Secondary outcome [7] 0 0
Core Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 24
Timepoint [7] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [8] 0 0
Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition14 (ADAS-Cog14) Score
Timepoint [8] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [9] 0 0
Core Phase: Change From Baseline up to Month 24 in the MMSE Score
Timepoint [9] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [10] 0 0
Core Phase: Change From Baseline up to Month 24 in the Functional Assessment Questionnaire (FAQ) Score
Timepoint [10] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [11] 0 0
Core Phase: Change From Baseline up to Month 24 in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score
Timepoint [11] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [12] 0 0
Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition11 (ADAS-Cog11) Score
Timepoint [12] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Secondary outcome [13] 0 0
Core Phase: Change From Last Dose in the CDR-SB Score
Timepoint [13] 0 0
From last dose in the core phase (up to Month 24) up to 3 months follow up (up to Month 27)
Secondary outcome [14] 0 0
Core Phase: Change From Last Dose in the ADCOMS
Timepoint [14] 0 0
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Secondary outcome [15] 0 0
Core Phase: Change From Last Dose in the ADAS-cog11 Score
Timepoint [15] 0 0
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Secondary outcome [16] 0 0
Core Phase: Change From Last Dose in the ADAS-cog14 Score
Timepoint [16] 0 0
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Secondary outcome [17] 0 0
Core Phase: Change From Last Dose in the MMSE Score
Timepoint [17] 0 0
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Secondary outcome [18] 0 0
Core Phase: Change From Last Dose in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score
Timepoint [18] 0 0
From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)
Secondary outcome [19] 0 0
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in CDR-SB Score
Timepoint [19] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Secondary outcome [20] 0 0
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADCOMS
Timepoint [20] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Secondary outcome [21] 0 0
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in MMSE Score
Timepoint [21] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Secondary outcome [22] 0 0
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in FAQ Score
Timepoint [22] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Secondary outcome [23] 0 0
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Score
Timepoint [23] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Secondary outcome [24] 0 0
Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score
Timepoint [24] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase
Secondary outcome [25] 0 0
Extension Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 12 of the Extension Phase
Timepoint [25] 0 0
Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

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
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2020
Sample size
Target
Accrual to date
Final
2212
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Facility #1 - Darlinghurst
Recruitment hospital [2] 0 0
Facility #1 - Macquarie Park
Recruitment hospital [3] 0 0
Facility #1 - Tumbi Umbi
Recruitment hospital [4] 0 0
Facility #1 - Brisbane
Recruitment hospital [5] 0 0
Facility #1 - Caulfield
Recruitment hospital [6] 0 0
Facility #1 - Geelong
Recruitment hospital [7] 0 0
Facility #1 - Heidelberg
Recruitment hospital [8] 0 0
Facility #1 - Malvern
Recruitment hospital [9] 0 0
Facility #2 - Melbourne
Recruitment hospital [10] 0 0
Facility #1 - Parkville
Recruitment hospital [11] 0 0
Facility #1 - Nedlands
Recruitment hospital [12] 0 0
Facility #3 - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2261 - Tumbi Umbi
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
3162 - Caulfield
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
3146 - Melbourne
Recruitment outside Australia
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Oklahoma
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Oregon
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Hessen
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Gera
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Kyoto
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Yamaguchi
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Incheon
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Guimarães
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Alicante
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Barcelona
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Bizkaia
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Gipuzkoa
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Illes Balears
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Murcia
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Madrid
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Valencia
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Cambridgeshire
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Cheshire
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Devon
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Dorset
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East Sussex
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Greater Manchester
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Hampshire
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Lanarkshire
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Lancashire
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Middlesex
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North East Somerset
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Oxfordshire
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Scotland
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South Yorkshire
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Surrey
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West Midlands
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Wilts
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Glasgow
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Guildford
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Biogen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02956486
Trial related presentations / publications
Bullich S, Mueller A, De Santi S, Koglin N, Krause S, Kaplow J, Kanekiyo M, Roe-Vellve N, Perrotin A, Jovalekic A, Scott D, Gee M, Stephens A, Irizarry M. Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02956486