- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02702102
Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Imaging Inflammation in Patients With Diffuse Lewy Body Disease
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 11C-PBR28 PET scans
Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28.
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Up to 20 millicuries
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute 11C-PBR28 binding (total distribution volume corrected for free fraction in plasma)
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative 11C-PBR28 binding
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William Kreisl, MD, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Parkinson Disease
- Inflammation
- Dementia
- Alzheimer Disease
- Lewy Body Disease
Other Study ID Numbers
- AAAQ0756
- 2P50AG008702-26 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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EIP Pharma IncWorldwide Clinical TrialsCompletedDementia With Lewy Bodies (DLB)United States, Netherlands
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Osaka UniversityCompletedDementia With Lewy Bodies (DLB)Japan
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Eisai Inc.CompletedDementias With Lewy BodiesUnited States
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Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
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Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)
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Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
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Eisai Co., Ltd.Completed
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National Institute of Mental Health (NIMH)Uniformed Services University of the Health Sciences; Suburban HospitalCompletedHealthy | Traumatic Brain Injury (TBI)United States
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Yale UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH)RecruitingHealthy | HIV Dementia | HIV Associated Neurocognitive Disorder | HIV EncephalitisUnited States
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University of ExeterRecruitingParkinson Disease | Neurodegenerative DiseasesUnited Kingdom
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James M Noble, MD, MS, CPH, FAANNational Institute on Aging (NIA)Enrolling by invitation