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This study is being done to learn about inflammation in the brain of those with Alzheimer's disease (AD). The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Both patients (with either mild cognitive impairment (MCI) or Alzheimer's disease) and healthy controls (participants without memory complaints or impairment) will be included in this study.
Inflammation likely plays a role in the damage to the brain caused by Alzheimer's disease.
Accurately measuring inflammation in the brain could provide new information about the mechanisms that cause Alzheimer's disease, and could help identify new treatments that reduce inflammation. Positron emission tomography (PET) imaging is a type of brain scanning method that allows investigators to measure small molecules in the brain. ER176-PET was recently developed as an improved method for measuring brain inflammation. However, ER176-PET has not yet been used in patients with Alzheimer's disease. The investigators propose to use ER176-PET imaging in subjects with mild cognitive impairment (a very early stage of Alzheimer's disease) or mild Alzheimer's disease to compare the amount of inflammation with that seen in older control subjects. The investigators will first use a "gold standard" method of measuring ER176 in brain that requires sampling arterial blood during the scan. The investigators will compare these results to those obtained using novel methods that don't require blood sampling. The investigators hope to show that ER176 is a useful tool for measuring inflammation in Alzheimer's disease, and that the investigators can develop a way to obtain ER176 PET scans that don't require arterial blood sampling.
This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special dye is injected into the body. Two types of dye will be used in this study: Florbetaben and 11C-ER176. Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. Florbetaben has been approved by the Food and Drug Administration to help diagnose Alzheimer's disease. 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive impairment | Experimental | Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia) |
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| No cognitive impairment | Active Comparator | Healthy Controls |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-ER176 | Drug | 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| 11C-ER176 Total Distribution Volume | Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling. | Up to one year from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 11C-ER176 Standardized Uptake Value Ratio | The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 positron emission tomography (PET) scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). This is a simplified quantification technique compared to the Total Distribution Volume, but is linearly related to it. Higher values indicate more neuroinflammation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Lao, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
Individual participant data will be available upon reasonable request from a qualified investigator.
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Up to two weeks after review and approval of request.
Investigator qualifications and previous work will be reviewed by PI. Subsequent email correspondence will relay technical criteria needed for access.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Impairment | Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia) 11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. |
| FG001 | No Cognitive Impairment | Healthy Controls 11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Data is analyzed for 7 out of the 9 enrolled participants. 2 participants either withdrew or screen failed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Impairment | Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia) 11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 11C-ER176 Total Distribution Volume | Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling. | Data is reflective of those with blood sampling only: 4 out of 6 cognitive impairment participants and 1 out of 1 no cognitive impairment participant. All 7 completers have 11C-ER176 imaging but only 5 have arterial blood sampling and therefore a Total Distribution Volume. | Posted | Mean | Full Range | mL/cm^3 | Up to one year from baseline |
|
Up to one 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 | Cognitive Impairment | Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia) 11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick J. Lao, PhD | Columbia University | 212-305-9079 | pjl2133@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 | Oct 18, 2019 | Jul 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
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|
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| Florbetaben | Drug | Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. |
|
|
| Up to one year from baseline |
| BG001 | No Cognitive Impairment | Healthy Controls 11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Cognitive Impairment | Healthy Controls 11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. |
|
|
| Secondary | 11C-ER176 Standardized Uptake Value Ratio | The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 positron emission tomography (PET) scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). This is a simplified quantification technique compared to the Total Distribution Volume, but is linearly related to it. Higher values indicate more neuroinflammation. | Data is analyzed for completers only: 6 out of 6 cognitive impairment participants and 1 out of 1 no cognitive impairment participant. Completers here meaning they have 11C-ER176 imaging and SUVRs. | Posted | Mean | Full Range | uptake value ratio | Up to one year from baseline |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | No Cognitive Impairment | Healthy Controls 11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |