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| ID | Type | Description | Link |
|---|---|---|---|
| IND 78868 | Other Identifier | U.S. Food and Drug Administration | |
| R01AG037212-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
| National Institute on Aging (NIA) | NIH |
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The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. The driving hypothesis of the study is that amyloid beta in the brain as measured by positron emission tomography positivity is associated with the onset of cognitive decline associated with late onset Alzheimer's disease.
This project is a sub-study of the Washington Heights-Inwood Community Aging Project, which is a multidisciplinary, epidemiological study of Alzheimer's disease and related neurodegenerative disorders. We will obtain positron emission tomography scans and simultaneous x-ray computed tomography scans using Florbetaben from Bayer on a selection of ongoing participants who will be selected on the basis of change in plasma levels of amyloid beta over time. Approximately 200 participants will receive scans beginning in 2009 and in the 2010-2012 assessment wave and then again in a 2014-2015 assessment wave. Our intention is to examine whether uptake of Florbetaben in the brain is associated with decline in cognition over the 10 years prior to the PET scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY 94-9172 | Experimental | BAY 94-9172 PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY 94-9172 (Florbetaben) | Drug | Measure of brain amyloid load using BAY 94-9172 PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Cognitive Change Over Time and Amyloid (Aβ) Deposition | We used PET imaging to measure presence of amyloid. The outcomes are cognitive z-scores, which had mean of zero and SD of 1, with no units. There are four cognitive domains (language, memory, processing speed, and visuospatial ability). Individual neuropsychological test Z-scores within each domain were averaged to get the mean domain z-scores. Finally, the four cognitive domain-specific Z-scores were then averaged into a global cognitive Z-score. A larger Z-score represents better cognitive performance. Latent growth curve model was used to test for the association between Aβ and cognitive change over time. The Beta weight is a coefficient from the model that indicates the difference in cognitive change between people with and without amyloid. A positive Beta weight indicates that Aβ deposition is associated with less decline in cognitive scores, a negative Beta weight indicates greater decline. The Beta weight is unitless, and it does not have a range. | up to 3 years and 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Mayeux, BS, MD, MSc | Columbia University | Principal Investigator |
| Yaakov Stern, BA, PhD | Columbia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20697031 | Background | Cosentino SA, Stern Y, Sokolov E, Scarmeas N, Manly JJ, Tang MX, Schupf N, Mayeux RP. Plasma ss-amyloid and cognitive decline. Arch Neurol. 2010 Dec;67(12):1485-90. doi: 10.1001/archneurol.2010.189. Epub 2010 Aug 9. | |
| 20205671 | Background | Forsberg A, Almkvist O, Engler H, Wall A, Langstrom B, Nordberg A. High PIB retention in Alzheimer's disease is an early event with complex relationship with CSF biomarkers and functional parameters. Curr Alzheimer Res. 2010 Feb;7(1):56-66. doi: 10.2174/156720510790274446. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BAY 94-9172 | BAY 94-9172 PET/CT BAY 94-9172 (Florbetaben): Measure of brain amyloid load using BAY 94-9172 PET/CT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | BAY 94-9172 | BAY 94-9172 PET/CT BAY 94-9172 (Florbetaben): Measure of brain amyloid load using BAY 94-9172 PET/CT |
| 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 | Relationship Between Cognitive Change Over Time and Amyloid (Aβ) Deposition | We used PET imaging to measure presence of amyloid. The outcomes are cognitive z-scores, which had mean of zero and SD of 1, with no units. There are four cognitive domains (language, memory, processing speed, and visuospatial ability). Individual neuropsychological test Z-scores within each domain were averaged to get the mean domain z-scores. Finally, the four cognitive domain-specific Z-scores were then averaged into a global cognitive Z-score. A larger Z-score represents better cognitive performance. Latent growth curve model was used to test for the association between Aβ and cognitive change over time. The Beta weight is a coefficient from the model that indicates the difference in cognitive change between people with and without amyloid. A positive Beta weight indicates that Aβ deposition is associated with less decline in cognitive scores, a negative Beta weight indicates greater decline. The Beta weight is unitless, and it does not have a range. | In this analysis we evaluated whether the presence of amyloid was related to previous decline in cognition in 116 subjects. Mean cognition summarized performance on several cognitive tests. were analyzed. Global amyloid burden was rated with a visual rating by 2 trained clinicians. | Posted | Count of Participants | Participants | No | up to 3 years and 10 months |
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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 | BAY 94-9172 | BAY 94-9172 PET/CT BAY 94-9172 (Florbetaben): Measure of brain amyloid load using BAY 94-9172 PET/CT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yaakov Stern | Columbia University | 212-342-1350 | ys11@columbia.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| 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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| 26221954 | Result | Gu Y, Razlighi QR, Zahodne LB, Janicki SC, Ichise M, Manly JJ, Devanand DP, Brickman AM, Schupf N, Mayeux R, Stern Y. Brain Amyloid Deposition and Longitudinal Cognitive Decline in Nondemented Older Subjects: Results from a Multi-Ethnic Population. PLoS One. 2015 Jul 29;10(7):e0123743. doi: 10.1371/journal.pone.0123743. eCollection 2015. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 160 |
| 0 |
| 160 |
| 0 |
| 160 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |