A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02956486

Run by

Eisai Co., Ltd.

People needed

2212

Starts

2016-10-20

Expected to finish

2020-01-15

Last updated by the study team

2021-02-03

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Core Study
• Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including
• Mini Mental State Examination score equal to or greater than 24
• Clinical Dementia Rating (CDR) global score of 0.5
• 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

You may not qualify if…

• 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
• Have lesions that could indicate a dementia diagnosis other than AD on brain MRI
• 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:
• Absolute lymphocyte count below the lower limit of normal (LLN)
• Thyroid stimulating hormone above normal range
• 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

Where it is running

• Facility #1 — Colton, California, United States
• Facility #1 — Costa Mesa, California, United States
• Facility #1 — Fullerton, California, United States
• Facility #1 — Imperial, California, United States
• Facility #1 — Irvine, California, United States
• Facility #1 — Lemon Grove, California, United States
• Facility #1 — Oceanside, California, United States
• Facility #2 — Oceanside, California, United States
• Facility #1 — Oxnard, California, United States
• Facility #1 — Panorama City, California, United States
• Facility #1 — San Diego, California, United States
• Facility #1 — Denver, Colorado, United States
• Facility #1 — Atlantis, Florida, United States
• Facility #1 — Aventura, Florida, United States
• Facility #2 — Aventura, Florida, United States
• Facility #1 — Boynton Beach, Florida, United States
• Facility #1 — Coral Gables, Florida, United States
• Facility #2 — Coral Gables, Florida, United States
• Facility #1 — Delray Beach, Florida, United States
• Facility #1 — Doral, Florida, United States
• Facility #1 — Hialeah, Florida, United States
• Facility #2 — Miami, Florida, United States
• Facility #11 — Miami, Florida, United States
• Facility #9 — Miami, Florida, United States
• Facility #1 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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