Alzheimer’s Disease Clinical Trials: 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer’s Disease (MissionAD1)
The name of this trial is MissionAD1. This 24-month treatment, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer’s Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat (proposed international nonproprietary name [INN]) (E2609).
Qualified participants for this study must:
• be 50-85 years old
• have 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
• have impaired episodic memory confirmed by a list learning task
• have positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography (PET) or cerebrospinal fluid assessment or both
• Have a study partner able to support the participant for duration of the study
Exclusion Criteria:
• 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 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 (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 LLN
– Thyroid stimulating hormone above normal range
– Abnormally low Vitamin B12 levels
• Participants at risk of increased risk of infection
• Have received any live/live attenuated vaccine in the 3 months before randomization
• Any chronic inflammatory disease that is not adequately controlled or that requires systemic or ocular immunosuppressive or immunomodulatory therapy
• Any other clinically significant abnormalities
• Severe visual or hearing impairment
• A prolonged 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.
For more information, please call (973) 601 0100 Option 6. You can also send an email to research@neuroci.com.
Clinicaltrials.gov Identifier: NCT02956486
