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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01268020
Eligibility Criteria:
Inclusion Criteria:
The following criteria will be met for inclusion of AD subjects in this study:
* The participant is 50 years or older.
* Written informed consent is obtained.
* Participants have a clinical diagnosis of probable Alzheimer disease in accordance with the DSM-IV-TR and according to (NINCDS/ADRDA) criteria.
* Clinical Dementia Rating Scale score ≤ 2.
* Modified Hachinski Ischemia Scale score of ≤ 4.
* Geriatric Depression Scale (GDS) ≤ 10.
* For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \[18F\]-FMH3 injection.
The following criteria will be met for inclusion of healthy control subjects in this study:
* The participant is 18 years or older.
* Written informed consent is obtained.
* Negative history of neurological or psychiatric illness based on evaluation by a research physician.
* Clinical Dementia Rating score = 0.
* For females, non-child bearing potential a negative urine or blood pregnancy test on day of \[18F\]-FMH3 injection.
Exclusion Criteria:
Alzheimer's subjects will be excluded from participation for the following reasons:
* The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
* The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
Healthy control subjects will be excluded from participation for the following reasons:
* The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
* The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
* The subject has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01268020
Study Brief:
Protocol Section:
NCT01268020