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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50AG008702-26 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 11C-PBR28 PET scans | Experimental | Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-PBR28 | Drug | Up to 20 millicuries |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute 11C-PBR28 Binding (Total Distribution Volume Corrected for Free Fraction in Plasma) | Using Arterial blood sampling and 11C-PBR28 PET scan uptake, a Vt was found (as opposed to an SUVR) for target regions. Volume of distribution (VT) of a radioligand is defined as the ratio of the radioligand concentration in tissue target region (CT, kBq·cm-3) to that in plasma (CP, kBq·mL-1) at equilibrium. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Relative 11C-PBR28 Binding | Standardized Uptake Value Ratio (SUVR) measured on PET scan using 11C-PBR28. | 1 year |
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Inclusion Criteria:
Inclusion criteria for patients:
Inclusion criteria for controls:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Kreisl, MD | Columbia University | Study Director |
| Patrick Lao, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 11C-PBR28 PET Scans | Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28. 11C-PBR28: Up to 20 millicuries |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 11C-PBR28 PET Scans | Elderly participants will receive one IV injection of up to 20 millicuries of 11C-PBR28. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute 11C-PBR28 Binding (Total Distribution Volume Corrected for Free Fraction in Plasma) | Using Arterial blood sampling and 11C-PBR28 PET scan uptake, a Vt was found (as opposed to an SUVR) for target regions. Volume of distribution (VT) of a radioligand is defined as the ratio of the radioligand concentration in tissue target region (CT, kBq·cm-3) to that in plasma (CP, kBq·mL-1) at equilibrium. | Posted | Mean | Standard Deviation | kBq·cm-3 / kBq·mL-1 | 1 year |
|
|
Up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 11C-PBR28 PET Scans | Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28. 11C-PBR28: Up to 20 millicuries |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Kreisl, MD | Columbia University | 212-305-9194 | wck2107@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2016 | Aug 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C526315 | (methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine |
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| participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
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| Secondary | Relative 11C-PBR28 Binding | Standardized Uptake Value Ratio (SUVR) measured on PET scan using 11C-PBR28. | Posted | Mean | Standard Deviation | SUV ratio | 1 year |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |