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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02702102
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria for patients:
1. Age 60 and older.
2. Meet criteria for either a) dementia with Lewy bodies, or b) Parkinson's disease dementia.
3. Written and oral fluency in English.
4. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
5. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
* Inclusion criteria for controls:
1. Age 60 and older.
2. Normal cognitive and motor function based on neurological examination.
3. Written and oral fluency in English.
4. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
5. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Exclusion Criteria:
1. Past or present history of certain other brain disorders.
2. Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries.
3. Contraindication to MRI scanning.
4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
6. Low affinity binding on TSPO genetic screen
7. Currently taking anticoagulant drugs (e.g., warfarin).
8. Women of childbearing potential.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02702102
Study Brief:
Protocol Section:
NCT02702102