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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02702102
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
William Charles Kreisl, Columbia University

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.


Condition or disease Intervention/treatment Phase
Diffuse Lewy Body Disease Dementia With Lewy Bodies Parkinson's Disease Dementia Drug: 11C-PBR28 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Inflammation in Patients With Diffuse Lewy Body Disease
Study Start Date : December 2015
Actual Primary Completion Date : September 4, 2019
Actual Study Completion Date : September 4, 2019


Arm Intervention/treatment
Experimental: 11C-PBR28 PET scans
Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28.
Drug: 11C-PBR28
Up to 20 millicuries




Primary Outcome Measures :
  1. Absolute 11C-PBR28 binding (total distribution volume corrected for free fraction in plasma) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Relative 11C-PBR28 binding [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702102


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
William Charles Kreisl
National Institute on Aging (NIA)
Investigators
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Principal Investigator: William Kreisl, MD Columbia University

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Responsible Party: William Charles Kreisl, Boris and Rose Katz Assistant Professor of Neurology (in the Taub Institute), Columbia University
ClinicalTrials.gov Identifier: NCT02702102    
Other Study ID Numbers: AAAQ0756
2P50AG008702-26 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Alzheimer Disease
Lewy Body Disease
Inflammation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Tauopathies