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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02016560
Eligibility Criteria:
Inclusion Criteria:
Exploratory Cognitively Healthy Subjects
* ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
* Mini-mental state examination (MMSE) ≥ 29
* No significant history of cognitive impairment
Exploratory MCI Subjects
* ≥ 50 years of age
* MMSE ≥ 24
* Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
* Have a study partner that can report on subject's activities of daily living
Exploratory AD Subjects
* ≥ 50 years of age
* MMSE \> 10
* Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD
* Have a study partner that can report on subject's activities of daily living
Confirmatory Subjects
* ≥ 50 years of age
* MMSE ≥ 20 and ≤ 27
* Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
* Have a study partner that can report on subject's activities of daily living
Exclusion Criteria:
* Current clinically significant psychiatric disease
* Evidence of structural brain abnormalities
* History of moderate or severe traumatic brain injury
* Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol or substance abuse or dependence
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have received or participated in a trial with investigational medications in the past 30 days
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02016560
Study Brief:
Protocol Section:
NCT02016560