A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease
Trial ID or NCT#
Status
Purpose
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.
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
Eligibility Criteria
- Core Study
- * Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including
- 1. Mini Mental State Examination score equal to or greater than 24 2. Clinical Dementia Rating (CDR) global score of 0.5 3. 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
- 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
- 1. Have lesions that could indicate a dementia diagnosis other than AD on brain MRI 2. 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:
- 1. Absolute lymphocyte count below the lower limit of normal (LLN) 2. Thyroid stimulating hormone above normal range 3. 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
- Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.
Investigator(s)
View on ClinicalTrials.gov