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:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT04616456
Eligibility Criteria:
\*\*Subjects must be located in close proximity to Brigham and Women's Hospital, Boston, MA in order to meet monitoring criteria outlined in study protocol.\*\*
Inclusion/Exclusion criteria:
Subject Inclusion Criteria:
1\. Probable MSA clinical diagnosis
Subject Exclusion Criteria:
1. Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
2. Individuals with bipolar disease, schizophrenia, psychotic disorder, or any severe psychiatric disorder
3. History of substance abuse disorder
4. Concurrent medical conditions that contraindicate study procedures
5. Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
6. Individuals with claustrophobia
7. Non-MRI compatible implanted devices
8. Individuals with a genotype indicating that they are low affinity binders of TSPO
9. Abnormal thyroid function (contingent upon free T3, free T4, and TSH levels \<10 mIU/L)
10. Renal impairment (RI)
11. Hepatic impairment (HI)
12. Systemic corticosteroid treatment in the past four weeks (excluding nasal or local treatment)
13. Individuals with significant cognitive impairment (i.e. MoCA score less than or equal to 20)
14. Brain MRI indicative of significant abnormality (i.e. prior hemorrhage or infarct)
15. Significant cardiac events within the past year (i.e. hospitalization for congestive heart failure, myocardial infarction, or arrhythmias requiring treatment).
16. Medical conditions that interfere with absorption or secretion of drugs (i.e. gastrointestinal disease)
17. Individuals diagnosed with Human Immunodeficiency Virus Infection Diagnosis (HIV +)
18. Any other clinically significant diagnosis that is currently unstable
19. Hematologic or solid malignancy diagnosis within the past 5 years
20. Medical procedure or surgery within four weeks prior to screening
21. Current treatment through use of any other investigational agent, dopamine antagonists, CYP1A2 inhibitors or inducers, CYP3A4 inhibitors or inducers, or CYP2B6 or CYP3A4 metabolized drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04616456
Study Brief:
Protocol Section:
NCT04616456