A 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease_ (MissionAD1)

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer's Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223496

Enrollment

1330

Registered

2017-03-31

Start date

2017-03-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early AD (Mild cognitive impairment due to AD and Mild AD dementia)

Interventions

investigational material(s) Generic name etc : E2609 INN of investigational material : Elenbecestat Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Mild cognitive impairment due to AD or mild AD dementia (2)Positive biomarker for brain amyloid pathology (3)Study partner able to support the participant for duration of the study

Exclusion criteria

Exclusion criteria: (1)Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD (2)Participants with a history of seizures within 5 years of Screening (3)History of transient ischemic attacks or stroke within 12 months of Screening (4)Psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, delusions, etc.) (5)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 (6)Have any contraindications to magnetic resonance imaging (MRI) scanning (7)Have lesions that could indicate a dementia diagnosis other than AD on brain MRI (8)Exhibit other significant pathological findings on brain MRI (9)Severe visual or hearing impairment (10)Malignant neoplasms within 5 years of Screening (11)Known or suspected history of drug or alcohol abuse (12)Taking prohibited medications

Design outcomes

Primary

Measure	Time frame
safety efficacy Core study: To determine whether E2609 is superior to placebo on the change from baseline in the CDR-SB at 24 months in subjects with Early AD Open label extension phase: To evaluate the long-term safety and tolerability of daily dosing with E2609 in subjects with Early AD	—

Secondary

Measure	Time frame
efficacy pharmacodynamics -	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026