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|NCT01677572 : Multiple Dose Study of BIIB037 (Recombinant, Fully Human Anti-A? IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease|
|Ages||Min: 50 Years Max: 90 Years|
Key Inclusion Criteria:
- Subjects must meet criteria for Prodromal Alzheimer's Disease (AD) or Mild
Alzheimer's Disease (AD):
1. Mini Mental State Examination (MMSE) score between 20-30,
2. Clinical Dementia Rating Scale (CDR) score of 0.5 or 1.0.
3. A free recall score of lesser or equal to 27 on the Free and Cued Selective
Reminding Test (FCSRT) for prodromal Alzheimer's Disease (AD).
- Subjects must have a positive florbetapir positron emission tomography (PET) amyloid
- Subjects must consent to apolipoprotein E (ApoE) genotyping.
- Apart from clinical diagnosis of Alzheimer's Disease (AD), subject must be in good
- Must have a reliable informant or caregiver.
Key Exclusion Criteria:
- Any medical or neurological condition (other than Alzheimer's Disease) that might be
a contributing cause of the subject's cognitive impairment.
- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of
consciousness in the past 1 year.
- Clinically significant psychiatric illness in past 6 months.
- Seizure in the past 3 years.
- Poorly controlled diabetes mellitus.
- History of unstable angina, myocardial infarction, chronic heart failure, or clinical
significant conduction abnormalities within 1 year prior to Screening.
- Indication of impaired renal or liver function.
- Have human immunodeficiency virus (HIV) infection.
- Have a significant systematic illness or infection in past 30 days.
- Brain MRI showing evidence of acute or sub-acute micro or macrohemorrhage, greater
than 4 microhemorrhages, cortical infarct or greater than one 1 lunar infarct.
- Any contraindications to brain MRI or positron emission tomography (PET) scans.
- Negative positron emission tomography (PET) scan with any amyloid-targeting ligand
within 48 weeks of Screening.
- Clinically significant 12-lead electrocardiogram (ECG) abnormalities.
- Alcohol or substance abuse in past 1 year.
- Taking blood thinners (except for aspirin at a prophylactic dose or less)
- Have changes in medications or doses of medication in past 4 weeks.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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