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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AG052633-01 | 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 is being done to learn about inflammation and amyloid in Alzheimer's disease. A type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and do tests to measure the participants' memory and thinking.
This study is being done to determine the relationship between inflammation, cognitive impairment, and amyloid burden in elderly subjects with different clinical and biomarker profiles of Alzheimer's disease (AD). Participants will undergo amyloid PET imaging with 18F-Florbetaben with target number of completers being 15 amyloid-positive elders with impairment, 15 amyloid-positive elders with normal cognition, 15 amyloid-negative elders with impairment, and 15 amyloid-negative elders with normal cognition. Subjects will undergo screen that includes neuropsychological testing, brain MRI, and PET imaging with 18F-florbetaben to define the above 4 groups. Subjects will have 11C-PBR28 PET imaging to measure the 18 kDa translocator protein (a marker of inflammation). Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of amyloid,tau, phospho-tau, and inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amyloid-positive with cognitive impairment (AD) | Experimental | Amyloid-positive patients who already have cognitive impairment at the time of enrollment. |
|
| Amyloid-positive without impairment (preclinical AD) | Active Comparator | Cognitively normal subjects who are amyloid-positive |
|
| Amyloid-negative with cognitive impairment | Active Comparator | Participants with cognitive impairment due to suspected non-AD pathophysiology |
|
| Amyloid-negative without impairment (normal aging) | Active Comparator | Cognitively normal subjects who are amyloid-negative on PET, and lack signs of neurodegeneration from other biomarkers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-PBR28 | Drug | 11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection. |
| Measure | Description | Time Frame |
|---|---|---|
| 11C-PBR28 Binding | In vivo quantification radioligand binding to TSPO expression on microglia in the brain, reported as standardized uptake value ratio (SUVR). | Up to 1 year from screening |
| Measure | Description | Time Frame |
|---|---|---|
| 18F-Florbetaben Binding | In vivo quantification of radioligand binding to Amyloid-Beta protein in the brain, reported as standardized uptake value ratio (SUVR). | Up to 1 year from screening |
| Cerebral Spinal Fluid (CSF) Biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J Lao | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33646153 | Derived | Klein J, Yan X, Johnson A, Tomljanovic Z, Zou J, Polly K, Honig LS, Brickman AM, Stern Y, Devanand DP, Lee S, Kreisl WC. Olfactory Impairment Is Related to Tau Pathology and Neuroinflammation in Alzheimer's Disease. J Alzheimers Dis. 2021;80(3):1051-1065. doi: 10.3233/JAD-201149. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive patients who already have cognitive impairment at the time of enrollment |
| FG001 | Amyloid-positive Without Impairment (Preclinical AD) | Cognitively normal subjects who are amyloid-positive |
| FG002 | Amyloid-negative With Cognitive Impairment | Participants with cognitive impairment due to suspected non-AD pathophysiology |
| FG003 | Amyloid-negative Without Impairment (Normal Aging) | Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive patients who already have cognitive impairment at the time of enrollment |
| BG001 | Amyloid-positive Without Impairment (Preclinical AD) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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-PBR28 Binding | In vivo quantification radioligand binding to TSPO expression on microglia in the brain, reported as standardized uptake value ratio (SUVR). | Posted | Mean | Standard Deviation | SUVR | Up to 1 year from screening |
|
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 | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive patients who already have cognitive impairment at the time of enrollment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soreness at IV injection site | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lao | Columbia University | 2123421351 | 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 | Jun 3, 2022 | Feb 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D007249 | Inflammation |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C526315 | (methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine |
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| 18F-Florbetaben | Drug | 18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection. |
|
|
| Lumbar puncture (optional) | Procedure | Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid. |
|
|
Protein analysis of cerebral spinal fluid.
| Up to 1 year from screening |
Cognitively normal subjects who are amyloid-positive
| BG002 | Amyloid-negative With Cognitive Impairment | Participants with cognitive impairment due to suspected non-AD pathophysiology |
| BG003 | Amyloid-negative Without Impairment (Normal Aging) | Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants with cognitive impairment due to suspected non-AD pathophysiology |
| OG003 | Amyloid-negative Without Impairment (Normal Aging) | Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers |
|
|
| Secondary | 18F-Florbetaben Binding | In vivo quantification of radioligand binding to Amyloid-Beta protein in the brain, reported as standardized uptake value ratio (SUVR). | Posted | Mean | Standard Deviation | SUVR | Up to 1 year from screening |
|
|
|
| Secondary | Cerebral Spinal Fluid (CSF) Biomarkers | Protein analysis of cerebral spinal fluid. | Some participants did not wish to do this procedure, so data was not collected from these participants. | Posted | Mean | Standard Deviation | ng/mL | Up to 1 year from screening |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Amyloid-positive Without Impairment (Preclinical AD) | Cognitively normal subjects who are amyloid-positive | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Amyloid-negative With Cognitive Impairment | Participants with cognitive impairment due to suspected non-AD pathophysiology | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Amyloid-negative Without Impairment (Normal Aging) | Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers | 0 | 17 | 0 | 17 | 2 | 17 |
| Headache | General disorders | Non-systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |