Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
50–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have a gradual and progressive change in memory function over more than 6 months.
Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
Objective evidence of cognitive impairment at Screening
Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
CDR Memory Box score of ≥0.5
Must consent to apolipoprotein E (ApoE) genotyping
Must have 1 informant/study partner
Must have amyloid beta positivity confirmed at Screening
You may not be if
Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
Indication of impaired renal or liver function
Alcohol or substance abuse in past 1 year
Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
