Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT02880956
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT02880956
Study Brief:
Protocol Section:
NCT02880956