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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02103894
Eligibility Criteria:
Inclusion Criteria:
For all subjects:
* Written informed consent or assent is obtained.
* Willing and able to cooperate with study procedures.
* For females, non-child bearing potential or negative urine pregnancy test on day of \[18F\]MNI-777 injection.
Alzheimer Disease subjects:
* The participant is 50 years or older.
* Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria (McKann, 1984)
* Modified Hachinski Ischemia Scale score of ≤ 4.
Parkinson's Disease subjects:
* The participant is 30 years or older.
* Participants have a clinical diagnosis of PD based on the UK Brain Bank Criteria (Hughes, et al., 1982).
* The duration of diagnosis of PD is \<20 years prior to the imaging visit
* PD subjects must be on stable doses of medications for a period of at least 30 days prior to the imaging visit.
* Treatment with dopamine replacement therapies or other symptomatic therapies for PD is permitted; however, subjects must be on a stable dose of medications 30 days prior to the imaging visit.
Progressive Supranuclear Palsy subjects:
* The participant is 30 years or older.
* Participants have a clinical diagnosis of PSP based on National Institute of Neurological Disorders and Stroke/ (NINDS) and the Society for PSP (SPSP) criteria (Litvan, et al. 1996).
Chronic Traumatic Encephalopathy subjects:
* The participant is 18 years or older.
* Subjects with a diagnosis of probable CTE based on a prior history of repetitive brain trauma and at least one concussion, and a current mood disorder (depression, apathy, irritability, suicidal ideation), cognitive symptoms (memory loss, impaired executive function) or behavioral symptoms (disinhibition, aggression and increased violence) (Jordan, 2013).
Frontal Temporal Dementia/Pick's disease subjects:
* The participant is 50 years or older.
* Participants have a clinical diagnosis of FTD based on consensus for clinical diagnosis of frontotemporal dementia (Neary, et al., 1998)
Healthy Control subjects:
* The participant is 18 - 85 years old.
* Negative history of neurological or psychiatric illness based on evaluation by a research physician.
* MMSE score must be 29 or above.
Exclusion Criteria:
All 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 (including gastrointestinal surgery).
* The subject has evidence of a structural lesion on MRI that may interfere with interpretation of PET imaging.
* 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 participated in another clinical study within the previous 30 days.
* Pregnancy or women who are nursing or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02103894
Study Brief:
Protocol Section:
NCT02103894