Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
TerminatedPhase 2Results postedLast updated 5 March 2021
What this trial tests
Phase 2 trial testing E2609 in Alzheimer Disease in 70 participants. Terminated before completion.
Adults 50 to 85, any sex, with Alzheimer Disease or Dementia, Alzheimer Type. 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: Number of Participants With Treatment Emergent Adverse Events (TEAEs)Primary· Up to 21 months
A TEAE is defined as an adverse event that emerges during treatment, having been absent at pre-treatment (Baseline) or re-emerges during treatment, having been present at pre-treatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.
Group
Value
95% CI
Core Phase: Placebo
15
Core Phase: Elenbecestat 5 mg Then 50 mg
15
Core Phase: Elenbecestat 15 mg Then 50 mg
18
Core Phase: Elenbecestat 50 mg
15
Core Phase: Number of Participants With Serious Adverse Events (SAEs)Primary· Up to 21 months
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
Group
Value
95% CI
Core Phase: Placebo
2
Core Phase: Elenbecestat 5 mg Then 50 mg
2
Core Phase: Elenbecestat 15 mg Then 50 mg
5
Core Phase: Elenbecestat 50 mg
1
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test ValuesPrimary· Up to 21 months
Markedly Abnormal Low: Lymphocytes
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
2
Core Phase: Elenbecestat 15 mg Then 50 mg
0
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Leukocytes
Group
Value
95% CI
Core Phase: Placebo
1
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
0
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Neutrophils
Group
Value
95% CI
Core Phase: Placebo
1
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
0
Core Phase: Elenbecestat 50 mg
1
Markedly Abnormal Low: Hemoglobin
Group
Value
95% CI
Core Phase: Placebo
1
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
0
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Calcium
Group
Value
95% CI
Core Phase: Placebo
1
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
0
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Potassium
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
1
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal High: Potassium
Group
Value
95% CI
Core Phase: Placebo
2
Core Phase: Elenbecestat 5 mg Then 50 mg
4
Core Phase: Elenbecestat 15 mg Then 50 mg
2
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal High: Alkaline Phosphatase
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
0
Core Phase: Elenbecestat 50 mg
1
Core Phase: Number of Participants With Markedly Abnormal Vital Sign ValuesPrimary· Month 0(Baseline,Week 2,Week 3,Week 4);Month 1(Week 5,Week 7);Month 2(Week 9,Week 11);Month 3(Week 13);Month 4(Week 17);Month 5(Week 21);Month 6(Week 27);Month 9(Week 40);Month 12(Week 53);Month 15(Week 66);Month 18(Week 79) and Follow-up at Month 1 and 3
Participants having no markedly abnormal vital sign values (no markedly abnormal high or no markedly abnormal low) in all core phase arms were not included in the data reported.
Markedly Abnormal Low: Temperature (Month 0: Baseline)
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
2
Core Phase: Elenbecestat 15 mg Then 50 mg
0
Core Phase: Elenbecestat 50 mg
2
Markedly Abnormal Low: Temperature (Month 0: Week 2)
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
2
Core Phase: Elenbecestat 50 mg
2
Markedly Abnormal Low: Temperature (Month 0: Week 3)
Group
Value
95% CI
Core Phase: Placebo
2
Core Phase: Elenbecestat 5 mg Then 50 mg
1
Core Phase: Elenbecestat 15 mg Then 50 mg
4
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Temperature (Month 0: Week 4)
Group
Value
95% CI
Core Phase: Placebo
1
Core Phase: Elenbecestat 5 mg Then 50 mg
3
Core Phase: Elenbecestat 15 mg Then 50 mg
1
Core Phase: Elenbecestat 50 mg
1
Markedly Abnormal High: Temperature (Month 0: Week 4)
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
1
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Temperature (Month 1: Week 5)
Group
Value
95% CI
Core Phase: Placebo
1
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
2
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Temperature (Month 1: Week 7)
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
1
Core Phase: Elenbecestat 15 mg Then 50 mg
3
Core Phase: Elenbecestat 50 mg
0
Markedly Abnormal Low: Temperature (Month 2: Week 9)
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
1
Core Phase: Elenbecestat 15 mg Then 50 mg
1
Core Phase: Elenbecestat 50 mg
2
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) FindingsPrimary· Up to 21 months
QTcF interval means corrected QT interval (QTc) calculated using Fridericia's formula.
At least one post-baseline increase of >30 millisecond (msec) in QTcF interval
Group
Value
95% CI
Core Phase: Placebo
2
Core Phase: Elenbecestat 5 mg Then 50 mg
4
Core Phase: Elenbecestat 15 mg Then 50 mg
4
Core Phase: Elenbecestat 50 mg
2
At least one post-baseline value of >450 msec in QTcF interval
Group
Value
95% CI
Core Phase: Placebo
1
Core Phase: Elenbecestat 5 mg Then 50 mg
6
Core Phase: Elenbecestat 15 mg Then 50 mg
4
Core Phase: Elenbecestat 50 mg
3
At least one post-baseline value of >480 msec in QTcF interval
Group
Value
95% CI
Core Phase: Placebo
0
Core Phase: Elenbecestat 5 mg Then 50 mg
0
Core Phase: Elenbecestat 15 mg Then 50 mg
1
Core Phase: Elenbecestat 50 mg
0
Extension Phase: Number of Participants With TEAEs and SAEsPrimary· Up to 34 months
TEAE: adverse event that emerges during treatment, having been absent at pre-treatment or reemerges during treatment, having been present at pre-treatment but stopped before treatment, or worsens in severity during treatment relative to pre-treatment state. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, regular measurement of vital signs, magnetic resonance imaging and electrocardiogram parameter values. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening (immediate risk of death fr
TEAEs
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
30
SAEs
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
6
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign ValuesPrimary· Up to 34 months
Markedly Abnormal High: Diastolic Blood Pressure
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
1
Markedly Abnormal Low: Diastolic Blood Pressure
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
1
Markedly Abnormal High: Systolic Blood Pressure
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
5
Markedly Abnormal High: Temperature
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
1
Markedly Abnormal Low: Temperature
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
10
Markedly Abnormal High: Weight
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
1
Extension Phase: Number of Participants With Markedly Abnormal ECG FindingsPrimary· Up to 34 months
QTcF interval means QTc interval calculated using Fridericia's formula.
At least one post-baseline increase of >30 msec in QTcF interval
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
2
At least one post-baseline value of >450 msec in QTcF interval
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
4
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test ValuesPrimary· Up to 34 months
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) FindingsPrimary· Up to 34 months
Brain MRIs are collected to assess for potential drug-related changes that might have constituted a safety concern. Safety brain MRI is assessed using a standardized procedure that included fluid-attenuated inversion recovery (FLAIR), gradient-echo, T1, and diffusion-weighted sequences to determine the presence of focal lesions including, but not limited to, evidence for ischemic and hemorrhagic stroke, subdural hematoma, neoplasm, arteriovenous malformation, micro and macrohemorrhages, superficial siderosis, lacunar infarcts, white matter abnormalities, and vasogenic edema. Participants with
Brain Vasogenic Edema
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
0
Brain Microhemorrhages
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
4
Brain White Matter Disease: Focal Lesions
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
25
Brain White Matter Disease: No Lesions
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
2
Area of superficial siderosis
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
1
Space occupying lesion (extra axial): Meningioma
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
1
Other pituitary lesion
Group
Value
95% CI
Extension Phase: Elenbecestat 50 mg
1
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of TreatmentSecondary· Month 1 (Week 5) and Month 18 (Week 79)
The measurement of the amyloid proteins Abeta(1-x) and Abeta(1-42), in CSF have been shown to be important biomarkers for alzheimer's disease.
Percent Change from Baseline in CSF Abeta(1-x) at Month 1 (Week 5)
Group
Value
95% CI
Core Phase: Placebo
6.63
± 12.545
Core Phase: Elenbecestat 5 mg Then 50 mg
-18.16
± 17.873
Core Phase: Elenbecestat 15 mg Then 50 mg
-36.43
± 16.026
Core Phase: Elenbecestat 50 mg
-56.66
± 14.431
Percent Change from Baseline in CSF Abeta(1-x) at Month 18 (Week 79)
Group
Value
95% CI
Core Phase: Placebo
-1.81
± NA
Core Phase: Elenbecestat 5 mg Then 50 mg
-33.86
± 11.039
Core Phase: Elenbecestat 15 mg Then 50 mg
-0.71
± NA
Core Phase: Elenbecestat 50 mg
33.98
± 160.017
Percent Change from Baseline in CSF Abeta(1-42) at Month 1 (Week 5)
Group
Value
95% CI
Core Phase: Placebo
-8.53
± 16.818
Core Phase: Elenbecestat 5 mg Then 50 mg
-9.43
± 22.798
Core Phase: Elenbecestat 15 mg Then 50 mg
-20.69
± 15.488
Core Phase: Elenbecestat 50 mg
-38.89
± 16.378
Percent Change from Baseline in CSF Abeta(1-42) at Month 18 (Week 79)
Group
Value
95% CI
Core Phase: Placebo
-6.50
± 24.809
Core Phase: Elenbecestat 5 mg Then 50 mg
-27.19
± 20.172
Core Phase: Elenbecestat 15 mg Then 50 mg
-24.02
± 19.949
Core Phase: Elenbecestat 50 mg
-56.77
± 5.312
Core Phase: Mean Concentration of Elenbecestat in CSFSecondary· Month 1 (Week 5) and Month 18 (Week 79)
Month 1 (Week 5)
Group
Value
95% CI
Core Phase: Elenbecestat 5 mg Then 50 mg
1.10
± 0.438
Core Phase: Elenbecestat 15 mg Then 50 mg
3.71
± 1.360
Core Phase: Elenbecestat 50 mg
9.93
± 3.568
Month 18 (Week 79)
Group
Value
95% CI
Core Phase: Elenbecestat 5 mg Then 50 mg
0.10
± 0
Core Phase: Elenbecestat 15 mg Then 50 mg
2.72
± 3.197
Core Phase: Elenbecestat 50 mg
14.46
± 3.411
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Core Phase: Placebo
Serious: 2/17 (12%)
Deaths: 0/17
Core Phase: Elenbecestat 5 mg Then 50 mg
Serious: 2/17 (12%)
Deaths: 0/17
Core Phase: Elenbecestat 15 mg Then 50 mg
Serious: 5/19 (26%)
Deaths: 0/19
Core Phase: Elenbecestat 50 mg
Serious: 1/17 (6%)
Deaths: 0/17
Extension Phase: Elenbecestat 50 mg
Serious: 6/41 (15%)
Deaths: 1/41
Serious adverse events (24 terms)
Reaction
System
Core Phase: Placebo
Core Phase: Elenbecestat 5…
Core Phase: Elenbecestat 1…
Core Phase: Elenbecestat 5…
Extension Phase: Elenbeces…
Appendicitis
Infections and infestations
—
—
—
—
—
Influenza
Infections and infestations
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
—
Localised infection
Infections and infestations
—
—
—
—
—
Syncope
Nervous system disorders
—
—
—
—
—
Major depression
Psychiatric disorders
—
—
—
—
—
Affective disorder
Infections and infestations
—
—
—
—
—
Agitation
Psychiatric disorders
—
—
—
—
—
Neuropsychiatric symptoms
Psychiatric disorders
—
—
—
—
—
Angina pectoris
Cardiac disorders
—
—
—
—
—
Chest pain
General disorders
—
—
—
—
—
Rib fracture
Injury, poisoning and procedural complications
—
—
—
—
—
Spinal column stenosis
Musculoskeletal and connective tissue disorders
—
—
—
—
—
Delusion
Psychiatric disorders
—
—
—
—
—
Meningoencephalitis viral
Infections and infestations
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
Pneumonia viral
Infections and infestations
—
—
—
—
—
Dementia Alzheimer's type
Nervous system disorders
—
—
—
—
—
Encephalopathy
Nervous system disorders
—
—
—
—
—
Asthenia
General disorders
—
—
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
—
—
Delirium
Psychiatric disorders
—
—
—
—
—
Diverticulum Intestinal Haemorrhagic
Gastrointestinal disorders
—
—
—
—
—
Wound Infection
Infections and infestations
—
—
—
—
—
Other adverse events (244 terms — click to expand)
Reaction
System
Core Phase: Placebo
Core Phase: Elenbecestat 5…
Core Phase: Elenbecestat 1…
Core Phase: Elenbecestat 5…
Extension Phase: Elenbeces…
Agitation
Psychiatric disorders
—
—
—
—
—
Upper Respiratory Tract Infection
Infections and infestations
—
—
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
—
—
Insomnia
Psychiatric disorders
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
Urinary Tract Infection
Infections and infestations
—
—
—
—
—
Dizziness
Nervous system disorders
—
—
—
—
—
Headache
Nervous system disorders
—
—
—
—
—
Abnormal Dreams
Psychiatric disorders
—
—
—
—
—
Depression
Psychiatric disorders
—
—
—
—
—
Cough
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
Dermatitis Contact
Skin and subcutaneous tissue disorders
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
Oedema Peripheral
General disorders
—
—
—
—
—
Bronchitis
Infections and infestations
—
—
—
—
—
Sinusitis
Infections and infestations
—
—
—
—
—
Arthropod Bite
Injury, poisoning and procedural complications
—
—
—
—
—
Contusion
Injury, poisoning and procedural complications
—
—
—
—
—
Laceration
Injury, poisoning and procedural complications
—
—
—
—
—
Ligament Sprain
Injury, poisoning and procedural complications
—
—
—
—
—
B-Lymphocyte Count Decreased
Investigations
—
—
—
—
—
Cd8 Lymphocytes Decreased
Investigations
—
—
—
—
—
Olfactory Test Abnormal
Investigations
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
—
—
—
—
Pain In Extremity
Musculoskeletal and connective tissue disorders
—
—
—
—
—
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a Phase 2 study to evaluate safety and efficacy in participants with Mild Cognitive Impairment due to Alzheimer's Disease/Prodromal Alzheimer's Disease (referred to as MCI/Prodromal) and mild to moderate dementia due to Alzheimer's Disease (referred to as mild to moderate AD). This study will have a Core Phase and an Extension Phase.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 Inc.
Last refreshed: 5 March 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/NCT02322021.