Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

• Status: Completed
• Trial end date: 2019-09-04
• Target enrollment: 0
• Participant gender: All

Summary

This study uses a special type of scan called a positron emission tomography (PET) scan to take pictures of the brain. During the PET scan, a special dye called 11C-PBR28 is injected into the body.

11C-PBR28 sticks to parts of the brain where there is inflammation. The purpose of this study is to see if 11C-PBR28 can detect inflammation in patients with Parkinson's disease dementia or dementia with Lewy bodies.

11C-PBR28 is considered a drug by the Food and Drug Administration. 11C-PBR28 is not a treatment for any disease. Rather, 11C-PBR28 can be used to measure inflammation in the brain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: William Charles Kreisl
• Collaborator: National Institute on Aging (NIA)

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.