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:
NCT04474405
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;
* MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
* Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)
Exclusion Criteria:
* Current clinically significant psychiatric disease.
* Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
* Claustrophobic or otherwise unable to tolerate the imaging procedure.
* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval \>450 msec).
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol abuse or substance abuse or dependence
* Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
* Required medications with a narrow therapeutic window
* Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session
* Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04474405
Study Brief:
Protocol Section:
NCT04474405