Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eisai Co., Ltd.
With
Biogen
Age
50–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be 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
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
