NCT02880956
Brief summary
This study seeks to evaluate the efficacy and safety of an active drug in subjects with Early Alzheimer's Disease.
Interventional study
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Age:
From 55 Years to 85 Years.
Inclusion Criteria:
- Subject who meets the National Institute on Aging and the Alzheimer's Association
(NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:
- Clinical Dementia Rating (CDR)-Global Score of 0.5
- Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
- Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory
Index (RBANS - DMI) score of 85 or lower
- Subject has a positive amyloid positron emission tomography (PET) scan.
- Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.
- The subject has an identified, reliable, study partner (e.g., family member).
- If using medications to treat symptoms related to AD, doses must be stable for at
least 12 weeks prior to randomization.
Exclusion Criteria:
- Subject has any contraindications or inability to tolerate brain magnetic resonance
imaging (MRI), PET scans or lumbar puncture.
- Subject has evidence of any other clinically significant neurological disorder other
than early AD.
- In the opinion of the investigator, the subject has any clinically significant or
uncontrolled medical or psychiatric illness, or has had an infection requiring medical
intervention in the past 30 days.
- Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
attack or required intervention for any of these conditions within 6 months of
Screening.
