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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00970333
Eligibility Criteria:
Inclusion Criteria:
* Alzheimer's disease patients will be recruited for this study. 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's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
* Clinical Dementia Rating Scale score ≤ 2.
* Modified Hachinski Ischemia Scale score of ≤ 4.
* For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \[18F\]-FEPPA injection.
Exclusion Criteria:
* Alzheimer's subjects will be excluded from participation for the following reasons:
* The subject has a history of significant cerebrovascular disease.
* 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.
* Pregnancy
Inclusion Criteria:
* The following criteria will be met for inclusion of PD subjects in this study:
* The participant is 30 years or older.
* Written informed consent is obtained.
* Participants have a clinical diagnosis of Parkinson disease (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia).
* Hoehn and Yahr ≤4.
* For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \[18F\]-FEPPA injection.
Exclusion Criteria:
* Parkinson'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 evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
* Pregnancy
Inclusion Criteria:
* Multiple Sclerosis Subject Selection. Subjects who have a clinical diagnosis of Multiple Sclerosis (MS) will be recruited for this study. The following criteria will be met for inclusion of MS subjects in this study:
* The participant is 18 years or older.
* Written informed consent is obtained.
* Participants have a clinical diagnosis of Multiple Sclerosis (per the 2005 Revised McDonald Criteria; Polman, et al., 2005).
* Kurtzke Expanded Disability Status Scale (EDSS) ≤ 7.5.
* For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \[18F\]-FEPPA injection.
Exclusion Criteria:
* MS 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.
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00970333
Study Brief:
Protocol Section:
NCT00970333