Adults 50 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) ScorePrimary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
The clinical dementia rating (CDR) scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mil
Group
Value
95% CI
Core Phase: Placebo
2.17
± 0.142
Core Phase: Elenbecestat 50 mg
1.99
± 0.146
Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)Primary· From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase
A TEAE is defined as an adverse event that emerged during treatment or within 28 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) were reported based on their safety assessments of laboratory tests, suicidal ideation and suicidal behavior, drug abuse potential
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
6
Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)Secondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), the Mini Mental State Examination (MMSE), and the CDR. Four items are from the ADAS-cog (A4 \[Delayed Word Recall\], A7 \[Orientation\], A8 \[Word Recognition\], A11 \[Word Finding\]); 2 items are from the MMSE (M1 \[Orientation Time\], M7 \[Drawing\]); 6 items are from the CDR (C1 \[Personal Care\], C2 \[Community Affairs\], C3 \[Home and Hobbies\], C4 \[Judgment and Problem Solving\], C5 \[Memory\], C6 \[Orientation\]). Composite sco
Group
Value
95% CI
Core Phase: Placebo
0.24
± 0.014
Core Phase: Elenbecestat 50 mg
0.23
± 0.015
Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)Secondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Amyloid PET scan assesses cerebral amyloid load using 3 tracers (florbetapir, florbetaben and flutemetamol) which is standardized into centiloids for evaluation of AD. Centiloid values on centiloid scale is based on mean composite SUVR in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global am
Group
Value
95% CI
Core Phase: Placebo
7.81
± 2.500
Core Phase: Elenbecestat 50 mg
-5.02
± 2.046
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 1.6Secondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate im
Group
Value
95% CI
Core Phase: Placebo
1.97
± 0.157
Core Phase: Elenbecestat 50 mg
1.74
± 0.169
Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6Secondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the ADAS-cog, the MMSE, and the CDR. Four items are from the ADAS-cog (A4 \[Delayed Word Recall\], A7 \[Orientation\], A8 \[Word Recognition\], A11 \[Word Finding\]); 2 items are from the MMSE (M1 \[Orientation Time\], M7 \[Drawing\]); 6 items are from the CDR (C1 \[Personal Care\], C2 \[Community Affairs\], C3 \[Home and Hobbies\], C4 \[Judgment and Problem Solving\], C5 \[Memory\], C6 \[Orientation\]). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where highe
Group
Value
95% CI
Core Phase: Placebo
0.23
± 0.017
Core Phase: Elenbecestat 50 mg
0.20
± 0.018
Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24Secondary· Up to Month 24 of the core phase
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate im
Group
Value
95% CI
Core Phase: Placebo
0.934
0.838 – 1.030
Core Phase: Elenbecestat 50 mg
0.926
0.828 – 1.024
Core Phase: Time to Worsening of CDR Score up to Month 24Secondary· Up to Month 24 of the core phase
The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate im
Group
Value
95% CI
Core Phase: Placebo
NA
NA – NA
Core Phase: Elenbecestat 50 mg
NA
24.07 – NA
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 24Secondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
Time (in months) to conversion to dementia for participants who were not clinically staged as having dementia at the core phase baseline (that is time from randomization to conversion to dementia in clinical diagnosis).
Group
Value
95% CI
Core Phase: Placebo
23.05
21.14 – 24.66
Core Phase: Elenbecestat 50 mg
21.40
20.45 – 24.43
Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition14 (ADAS-Cog14) ScoreSecondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall \[0-10\], Commands \[0-5\], Constructional Praxis \[0-5\], Delayed Word-recall \[0-10\], Naming Objects/Fingers \[0-5\], Ideational Praxis \[0-5\], Orientation\[0-8\], Word Recognition \[0-12\], Remembering Test Instructions \[0-5\], Comprehension\[0-5\], Word Finding Difficulty \[0-5\], Spoken Language Ability \[0-5\], Executive Function \[0-5\], and Number Cancellation \[0-5\] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The tota
Group
Value
95% CI
Core Phase: Placebo
5.38
± 0.490
Core Phase: Elenbecestat 50 mg
4.95
± 0.520
Core Phase: Change From Baseline up to Month 24 in the MMSE ScoreSecondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
The MMSE is a cognitive instrument commonly used for screening purposes, for staging of disease severity and is often measured longitudinally in AD clinical studies to follow disease progression and treatment effects. MMSE is composed of 30 questions grouped into domains (Orientation to Time \[0-5\], Orientation to Place \[0-5\], Registration \[0-3\], Attention and Calculation \[0-5\], Recall \[0-3\], Naming \[0-2\], Repetition \[0-1\], Comprehension \[0-3\], Reading \[0-1\], Writing \[0-1\], Drawing \[0-1\]). For each of the MMSE domains, six items are computed (Orientation to Time \[0-5\], O
Group
Value
95% CI
Core Phase: Placebo
-2.87
± 0.234
Core Phase: Elenbecestat 50 mg
-2.87
± 0.241
Core Phase: Change From Baseline up to Month 24 in the Functional Assessment Questionnaire (FAQ) ScoreSecondary· Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase
FAQ scores 10 items \& measures activities of daily living (paying bills/balancing checkbook, assembling tax records, shopping alone for clothes or groceries, playing game of skill such as bridge or chess/working on a hobby, heating water \& turning off stove, preparing balanced meal, keeping track of current events, paying attention \& understanding television program, remembering appointments, driving or traveling out of neighborhood). Each item is rated as follows: 0=Normal, 1=Has difficulty but does by self, 2=Requires assistance, 3=Dependent, or 8=Not Applicable. The total score is the su
Group
Value
95% CI
Core Phase: Placebo
5.20
± 0.448
Core Phase: Elenbecestat 50 mg
5.32
± 0.459
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to approximately 27 months (including 3 months follow up) for the Core Phase and up to approximately 6 months (including 1 month follow up) for the Extension Phase.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Core Phase: Placebo
Serious: 117/1105 (11%)
Deaths: 6/1105
Core Phase: Elenbecestat 50 mg
Serious: 134/1099 (12%)
Deaths: 3/1099
Extension Phase: Elenbecestat 50 mg
Serious: 0/18 (0%)
Deaths: 0/18
Serious adverse events (236 terms)
Reaction
System
Core Phase: Placebo
Core Phase: Elenbecestat 5…
Extension Phase: Elenbeces…
Fall
Injury, poisoning and procedural complications
—
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Influenza
Infections and infestations
—
—
—
Syncope
Nervous system disorders
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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· NA
· active not recruiting
NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
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· recruiting
NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Co., Ltd.
Last refreshed: 3 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02956486.