search
Back to results

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

Primary Purpose

Diffuse Lewy Body Disease, Dementia With Lewy Bodies, Parkinson's Disease Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
11C-PBR28
Sponsored by
William Charles Kreisl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diffuse Lewy Body Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

11C-PBR28 PET scans

Arm Description

Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28.

Outcomes

Primary Outcome Measures

Absolute 11C-PBR28 binding (total distribution volume corrected for free fraction in plasma)

Secondary Outcome Measures

Relative 11C-PBR28 binding

Full Information

First Posted
March 3, 2016
Last Updated
October 7, 2019
Sponsor
William Charles Kreisl
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT02702102
Brief Title
Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Official Title
Imaging Inflammation in Patients With Diffuse Lewy Body Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 4, 2019 (Actual)
Study Completion Date
September 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Charles Kreisl
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This study is being done to see if 11C-PBR28 could be useful in diffuse Lewy body disease. Diffuse Lewy Body Disease refers to subjects with either Parkinson's disease dementia or dementia with Lewy bodies. The hypothesis is that 11C-PBR28 binding will be greater in patients with diffuse Lewy body disease than in controls, with largest differences in temporal and limbic regions of the brain. Participants will have a medical history and examination. This will include questions about thinking and memory. Participants will have blood drawn for routine lab tests. Blood will also be tested for a special genetic test to make sure the 11C-PBR28 scan will work. A special genetic blood test will also be done to see if participants have genes that are associated with dementia with Lewy bodies or other causes of dementia. Participants will not receive the results of these special genetic tests. Participants will also have a magnetic resonance imaging (MRI) scan of the brain. If a participant still meet the inclusion and exclusion criteria after these procedures are done, then the participant will have one PET scan using 11C-PBR28. This scan will take place at the Columbia University Medical Center Kreitchman PET Center. On the day of the PET scan you will have an intravenous (IV) catheter (tube) placed in the participant's arm. The participant will also have an arterial catheter placed in an artery of your wrist. Participant will be asked to lay down on a PET scanner. A CT scan will be taken of the participant's head. A small amount of 11C-PBR28 will be injected into the IV. A member of the study team will draw blood from the arterial catheter. The PET scan will last 90 minutes. The participant will be asked to lay still during the scan. The amount of radiation from the 11C-PBR28 PET scan is up to 20 millicuries. Similar amounts of 11C-PBR28 have been given to over 100 human subjects in prior studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Lewy Body Disease, Dementia With Lewy Bodies, Parkinson's Disease Dementia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
11C-PBR28 PET scans
Arm Type
Experimental
Arm Description
Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28.
Intervention Type
Drug
Intervention Name(s)
11C-PBR28
Intervention Description
Up to 20 millicuries
Primary Outcome Measure Information:
Title
Absolute 11C-PBR28 binding (total distribution volume corrected for free fraction in plasma)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Relative 11C-PBR28 binding
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Kreisl, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs