Phase 2
N=5
Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Diffuse Lewy Body Disease · Dementia With Lewy Bodies · Parkinson's Disease Dementia
Bottom Line
View on ClinicalTrials.gov: NCT02702102 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Absolute 11C-PBR28 Binding (Total Distribution Volume Corrected for Free Fraction in Plasma) — 0.15 kBq·cm-3 / kBq·mL-1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 11C-PBR28 (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute 11C-PBR28 Binding (Total Distribution Volume Corrected for Free Fraction in Plasma) |
0.15 | — |
| SECONDARY Relative 11C-PBR28 Binding |
0.94 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Inclusion criteria for patients:
- Age 60 and older.
- Meet criteria for either a) dementia with Lewy bodies, or b) Parkinson's disease dementia.
- Written and oral fluency in English.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- 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:
- Age 60 and older.
- Normal cognitive and motor function based on neurological examination.
- Written and oral fluency in English.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- 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
- Past or present history of certain other brain disorders.
- Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries.
- Contraindication to MRI scanning.
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
- Low affinity binding on TSPO genetic screen
- Currently taking anticoagulant drugs (e.g., warfarin).
- Women of childbearing potential.
Data sourced from ClinicalTrials.gov (NCT02702102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.