Summary

for people ages 50-85 (full criteria)
at UCLA
study started
estimated completion

Description

Summary

The name of this trial is MissionAD2. 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 end points for the studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280) will be pooled for a combined total of 1900 participants.

Official Title

A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

Keywords

Alzheimer's Disease Elenbecestat E2609 Early Alzheimer's Disease Prodromal Alzheimer's Disease Dementia Dementia, Alzheimer's type Mild Cognitive Impairment MissionAD2 Alzheimer Disease Elenbecestat (E2609) Core Study: Elenbecestat (E2609) 50 mg

Eligibility

You can join if…

Open to people ages 50-85

Core Study

  • Mild cognitive impairment due to AD or mild AD dementia including
  • MMSE score equal to or greater than 24
  • 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 PET or CSF AD assessment or both

Extension Phase

•Participants who complete the Core Study

You CAN'T join 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 (e.g., 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 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 (eg, 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 (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

Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.

Locations

  • Facility #1 in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Facility #1 in progress, not accepting new patients
    Irvine California 92614 United States
  • Facility #1 terminated
    Santa Monica California 90404 United States
  • Facility #2 in progress, not accepting new patients
    Santa Ana California 92704 United States
  • Facility #1 terminated
    Santa Ana California 92705 United States
  • Facility #1 in progress, not accepting new patients
    Laguna Hills California 92653 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eisai Co., Ltd.
ID
NCT03036280
Phase
Phase 3
Study Type
Interventional
Last Updated