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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG052633-02 | U.S. NIH Grant/Contract | View source | |
| 2R56AG034189-06A1 | U.S. NIH Grant/Contract | View source | |
| K24AG045334 | U.S. NIH Grant/Contract | View source | |
| R01AG055299 | U.S. NIH Grant/Contract | View source | |
| R01AG050440-02S1 | 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 tau tangles in Alzheimer's disease. A type of positron emission tomography (PET) scan is used to measure the abnormal accumulation of protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and to tests to measure the participant's memory and thinking.
This study is being done to determine the relationship between tau tangles and cognitive impairment in elderly subjects with and without Alzheimer's disease (AD). Subjects will undergo screen that includes neuropsychological testing and brain MRI. This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special radioactive dye called 18F-MK-6240 is injected into the body. 18F-MK-6240 sticks to abnormal tangles made of the protein tau. Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of biomarkers.
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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) |
|
| No cognitive impairment | Active Comparator | Healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-MK-6240 | Drug | 18F-MK-6240 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| 18F-MK-6240 Binding | Standardized uptake value ratio (SUVr) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers. | Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation. | One year follow-up |
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Inclusion Criteria:
Age 50 and older.
Meet criteria for either
Subjects unable to provide informed consent must have a surrogate decision maker.
Written and oral fluency in English or Spanish.
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| 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 | No Cognitive Impairment | Healthy participants without cognitive impairment |
| FG001 | Cognitive Impairment | Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Cognitive Impairment | Healthy participants without cognitive impairment |
| BG001 | Cognitive Impairment | Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia |
| 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 | 18F-MK-6240 Binding | Standardized uptake value ratio (SUVr) | Posted | Mean | Standard Deviation | SUVr | 1 day |
|
|
During the scanning procedure (1 day), and at 1 year follow-up
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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 | No Cognitive Impairment | Healthy participants without cognitive impairment | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore arm from IV placement | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lao, PhD | Columbia University | 212-342-1399 | 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 | Dec 21, 2022 | Mar 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| 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 |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Lumbar Puncture (optional) | Procedure | Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid. |
|
| BG002 | 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers. | Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation. | Posted | Number | correlation coefficient (r) | One year follow-up |
|
|
|
| 43 |
| 0 |
| 43 |
| 4 |
| 43 |
| EG001 | Cognitive Impairment | Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia | 0 | 28 | 0 | 28 | 4 | 28 |
| Elevated blood pressure | Blood and lymphatic system disorders | Systematic Assessment |
|
| hypoglycemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| lightheadedness | General disorders | Systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |