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| ID | Type | Description | Link |
|---|---|---|---|
| A534255 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/GER-AD DEV | Other Identifier | UW Madison | |
| Protocol Version 8/26/2021 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Cerveau Technologies, Inc. | INDUSTRY |
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This is a longitudinal, observational study evaluating the imaging characteristics of the tau PET radioligand [18F]MK-6240 in Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and Healthy Volunteer (HV) subjects. Up to 42 subjects, including approximately 28 MCI/mild AD subjects, up to 5 moderate AD subjects, and 9 similarly aged HV subjects will be consented and screened. Imaging procedures include [11C]PiB to evaluate amyloid deposition, [18F]MK-6240 PET, and structural MRI. All subjects complete an evaluable baseline [18F]MK-6240 PET scan, as well as scans at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Experimental | All subjects will complete PET imaging sessions evaluating the tau PET radioligand [18F]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All Subjects | Drug | All subjects will be given the experimental tau PET radioligand [18F]MK-6240 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake | Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Correlation Between the Change in [18F]MK-6240 Uptake and the Change in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Using Items 1-11 | This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The ADAS-cog is one of the most frequently used tests to measure cognition in clinical trials in AD. The first 11 items of the ADAS-cog were used for this outcome. The ADAS was developed as a two-part scale: one that measured cognitive functions and one that measured non-cognitive functions such as mood and behavior. Most current research, including this study, uses the ADAS-Cog, which is the sub-scale that measures cognitive ability. The ADAS-cog score is based on incorrect items or errors and has a range of 0-50, where lower scores indicate better cognitive functioning. |
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Inclusion Criteria for all subjects:
Inclusion Criteria for Healthy Volunteers
Inclusion Criteria for Subjects with a Diagnosis of MCI or Dementia Due to AD
Exclusion Criteria for all subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | As described in the study eligibility criteria:
|
| FG001 | Mild Cognitive Impairment | As described in the study eligibility criteria:
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| FG002 | Dementia | As described in the study eligibility criteria:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | As described in the study eligibility criteria:
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| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake | Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia. | 26 of the 27 participants completed the 12 month interval | Posted | Mean | Standard Deviation | SUVR | Baseline to 12 months |
|
Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
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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 | Dementia | All subjects will complete PET imaging sessions evaluating the tau PET radioligand [18F]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points. All Subjects: All subjects will be given the experimental tau PET radioligand [18F]MK-6240 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reaction | General disorders | CTCAE (Unspecified) | Systematic Assessment |
This study included a small sample size of 6 healthy volunteers, 8 Mild Cognitive Impairment, and 13 Dementia subjects. This limits the statistical conclusions of the study. The study subjects were all non-hispanic, white participants. This limits the generalizability of the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sterling Johnson | University of WI Alzheimer's Disease Research Center | 608-262-9549 | scj@medicine.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2021 | Apr 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2020 | Apr 14, 2023 | SAP_001.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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| Baseline to 12 months |
| Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Clinical Dementia Rating Scale (CDR). | This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The CDR was developed primarily for use in persons with dementia of the Alzheimer type. The six domains of CDR are: Memory, Orientation, Judgment and Problem-solving, Community Affairs, Home and Hobbies, and Personal Care. Each domain is rated on a 5-point scale of functioning: 0 no impairment; 0.5 questionable impairment; 1 mild impairment; 2 moderate impairment; and 3 severe impairment. The Sum of Boxes is the score used which is simply the sum of the 6 Domain Box Scores. The range is 0-18 with lower scores indicating better cognitive function. | Baseline to 12 months |
| Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Mini-Mental Status Exam (MMSE) | This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The MMSE is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used as screening tool for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus, making it an effective way to document an individual's response to treatment. The range is 0-30 with higher scores indicating better cognitive functioning. | Baseline to 12 months |
| Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake | Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia. | Baseline to 24 months |
| Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake | Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia. | Baseline to 6 months |
| Mild Cognitive Impairment |
As described in the study eligibility criteria:
|
| BG002 | Dementia | As described in the study eligibility criteria:
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Mild Cognitive Impairment | As described in the study eligibility criteria:
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| OG002 | Dementia | As described in the study eligibility criteria:
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| Secondary | The Correlation Between the Change in [18F]MK-6240 Uptake and the Change in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Using Items 1-11 | This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The ADAS-cog is one of the most frequently used tests to measure cognition in clinical trials in AD. The first 11 items of the ADAS-cog were used for this outcome. The ADAS was developed as a two-part scale: one that measured cognitive functions and one that measured non-cognitive functions such as mood and behavior. Most current research, including this study, uses the ADAS-Cog, which is the sub-scale that measures cognitive ability. The ADAS-cog score is based on incorrect items or errors and has a range of 0-50, where lower scores indicate better cognitive functioning. | 26 of the 27 participants completed the 12 month interval | Posted | Number | Spearman Rho | Baseline to 12 months |
|
|
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| Secondary | Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Clinical Dementia Rating Scale (CDR). | This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The CDR was developed primarily for use in persons with dementia of the Alzheimer type. The six domains of CDR are: Memory, Orientation, Judgment and Problem-solving, Community Affairs, Home and Hobbies, and Personal Care. Each domain is rated on a 5-point scale of functioning: 0 no impairment; 0.5 questionable impairment; 1 mild impairment; 2 moderate impairment; and 3 severe impairment. The Sum of Boxes is the score used which is simply the sum of the 6 Domain Box Scores. The range is 0-18 with lower scores indicating better cognitive function. | 26 of the 27 participants completed the 12 month interval | Posted | Number | Spearman Rho | Baseline to 12 months |
|
|
|
| Secondary | Correlate the Changes in [18F]MK-6240 Uptake and Changes in Clinical Cognitive Assessments by Mini-Mental Status Exam (MMSE) | This outcome is correlational and therefore the arms/groups are collapsed to All Subjects so that we can assess the overall pattern of relationship between cognition and tau signal across the entire continuum of Alzheimer's disease. The MMSE is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used as screening tool for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus, making it an effective way to document an individual's response to treatment. The range is 0-30 with higher scores indicating better cognitive functioning. | 26 of the 27 participants completed the 12 month interval | Posted | Number | Spearman Rho | Baseline to 12 months |
|
|
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| Secondary | Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake | Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia. | 26 of the 27 participants completed the 24 month interval | Posted | Mean | Standard Deviation | SUVR | Baseline to 24 months |
|
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| Secondary | Change in [18F]MK-6240 Standard Uptake Value Ratio (SUVR) Uptake | Composite mean SUVR across standard regions including: numerator was the entorhinal, amygdala, fusiform, inferior temporal, middle temporal cortex; denominator was the inferior cerebellum cortex. The SUVR is a ratio and has a theoretic interpretable minimum of 1.0. This primary outcome is reported by the three primary groups: Healthy Volunteers, Mild Cognitive Impairment, and Dementia. | 26 of the 27 participants completed the 6 month interval | Posted | Mean | Standard Deviation | SUVR | Baseline to 6 months |
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| 0 |
| 13 |
| 0 |
| 13 |
| 3 |
| 13 |
| EG001 | Healthy Volunteer | All subjects will complete PET imaging sessions evaluating the tau PET radioligand [18F]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points. All Subjects: All subjects will be given the experimental tau PET radioligand [18F]MK-6240 | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Mild Cognitive Impairment | All subjects will complete PET imaging sessions evaluating the tau PET radioligand [18F]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points. All Subjects: All subjects will be given the experimental tau PET radioligand [18F]MK-6240 | 0 | 8 | 0 | 8 | 0 | 8 |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Infusion Site Extravasation | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |