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:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT03901105
Eligibility Criteria:
Scan Reader Criteria (5 total readers):
* Board-certified in radiology or nuclear medicine
* Professional experience interpreting PET scans
Scan Criteria (205 total scans):
* Former enrollment in AZES Study
* Flortaucipir scan at baseline
* clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months
Scan Study Population (AZES Study):
* 55 to 85 years
* MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association criteria (Albert 2011
* mini-mental status exam (MMSE) of 20 to 30 inclusive
* CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score ≥ 0.5, and a score of ≤85 on the Delayed Memory Index of the Repeatable Battery for the Assessment of Neuropsychological Status.
* Amyloid positive status confirmed by florbetapir PET or lumbar puncture
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT03901105
Study Brief:
Protocol Section:
NCT03901105