CompletedPhase 1

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort

Lead sponsor

Eisai Inc.

Asset

Elenbecestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoint

•Safety and tolerability as evidenced by the number of subjects

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDE2609-A001-001

NCT IDNCT01294540

Timeline

Milestones

Study start2010-12 (month precision)

Study first posted2011-02-11estimated

Primary completion2011-10actual (month precision)

Study completion2011-12actual (month precision)

Last update posted2013-08-29estimated

Assets

Drug assets

Elenbecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age30 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

Inclusion:

•Healthy males and females

•Aged 30 to 55 years, inclusive (Cohorts 1 through 5); aged 65 to 85 years, inclusive (Cohort 6)

•Body mass index (BMI) of 18 to 32kg/m^2 at Screening

•Additional inclusion criteria for Cohort 6 (healthy elderly subjects)

Exclusion

•Females of child-bearing potential

•Personal or family history of neurological abnormalities

•Any clinical abnormality of the electrocardiogram (ECG)at Screening and check-in

•A family history of cardiac abnormalities

•Thyroid abnormalities

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Safety and tolerability as evidenced by the number of subjects with adverse events

Time frame:38 days

event count, event

Secondary/protocol endpoint

To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses

Time frame:4 days

ratio, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.