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| ID | Type | Description | Link |
|---|---|---|---|
| A534255 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/GER-AD DEV | Other Identifier | UW Madison | |
| Protocol Version 3/7/2024 | Other Identifier | UW Madison | |
| R01AG062285 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The overarching goal of this project is to use [C-11]UCB-J to obtain spatial information on neuronal synapse abundance and inform Alzheimer's disease (AD) progression. The investigators propose to collect longitudinal amyloid, tau, and Synaptic vesicle glycoprotein 2A (SV2A) positron emission tomography (PET) in participants in the Wisconsin Alzheimer's Disease Research Center (ADRC) and Wisconsin Registry for Alzheimer's Prevention (WRAP) across the clinical stages of AD, including cognitively unimpaired biomarker negative, unimpaired biomarker positive, mild cognitive impairment (MCI), and dementia due to AD.
Synaptic loss is a major feature of symptomatic AD. Conversely, abundance of synapses may confer resilience to cognitive decline in the presence of AD pathology. The pathology-defining features of AD are amyloid plaques and neurofibrillary tangles and their presence and distribution can be spatially estimated in-vivo with amyloid and tau PET. Although these biomarkers can inform on the degree and location of pathology, they do not provide an indicator of their effect on collocated or extended in-network neural damage including synaptic density.
SV2A is expressed ubiquitously in synapses and the capability of assessing SV2A in vivo may provide a direct indicator of synaptic health. Such information would be of high importance for staging the level of synaptic loss or conversely synaptic abundance in the AD continuum and may potentially improve prognostic precision. The PET radioligand [C-11]UCB-J is a marker of SV2A.
The overarching goal of this project is to use [C-11]UCB-J to obtain spatial information on neuronal synapse abundance and inform upon disease progression. The investigators propose to collect longitudinal amyloid, tau, and SV2A PET in participants in the Wisconsin ADRC and WRAP across the clinical stages of AD, including cognitively unimpaired biomarker negative, unimpaired biomarker positive, MCI, and dementia due to AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitively Impaired plus Cognitive Unimpaired Participants | Experimental | Participants include both cognitively impaired and unimpaired populations to populate a single model to examine variables within the group as a whole.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB-J | Drug | PET imaging with UCB-J |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ROC AUCs (MCI/AD vs Cognitively Unimpaired (CU)) for Medial Temporal Lobe (MTL) UCB-J Distribution Volume Ratio (DVR) and Hippocampal Volume | DeLong's method will test whether the MTL UCB-J receiver-operator characteristic (ROC) area under the curve (AUC) has better mild cognitive impairment/probable AD dementia (MCI/AD) prediction accuracy than the hippocampal volume ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, hippocampal volume. | Baseline |
| ROC AUCs (MCI/AD vs CU) for MTL UCB-J and Hippocampal Cingulum Neurite Density Index | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the hippocampal cingulum neurite density index ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, hippocampal cingulum neurite density index. | Baseline |
| Annual Rate of Change in UCB-J DVR | Linear mixed effects regression will model UCB-J distribution volume ratio (DVR) as a function of time since baseline. 11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density. Participants' synaptic density was examined as a change per year. A positive number would mean an increase in synaptic density, a negative number means a decrease. | Baseline and 2 years |
| Baseline Diagnosis Group Differences in Annual Rate of Change in UCB-J DVR |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between ROC AUCs (MCI/AD vs CU) for Medial Temporal Lobe (MTL) UCB-J Distribution Volume Ratio (DVR) and Cerebrospinal Fluid (CSF) Neurofilament Light Chain Protein (NfL) | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the cerebrospinal fluid (CSF) neurofilament light chain protein (NfL) ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, CSF NfL. |
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Inclusion Criteria:
Cognitively unimpaired adults-
Mild dementia and amnestic Mild Cognitive Impairment-
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Bendlin, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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The intent of the study was observational, to characterize synaptic density across disease stages, the groups shown in the Baseline Characteristic Section are non-randomized subgroups within a single study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitively Impaired Plus Cognitive Unimpaired Participants | Participants include both cognitively impaired and unimpaired populations to populate a single model to examine variables within the group as a whole.
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The intent of the study was observational, to characterize synaptic density across disease stages, the groups shown in the Baseline Characteristic Section are non-randomized subgroups within a single study arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitively Unimpaired | Results of most recent testing with the source cohort indicate the participant is cognitively unimpaired as judged by consensus or expert review. |
| BG001 | Cognitively Impaired |
| 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 | ROC AUCs (MCI/AD vs Cognitively Unimpaired (CU)) for Medial Temporal Lobe (MTL) UCB-J Distribution Volume Ratio (DVR) and Hippocampal Volume | DeLong's method will test whether the MTL UCB-J receiver-operator characteristic (ROC) area under the curve (AUC) has better mild cognitive impairment/probable AD dementia (MCI/AD) prediction accuracy than the hippocampal volume ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, hippocampal volume. | Posted | Number | 95% Confidence Interval | probability | Baseline |
|
data collected during study contact, up to 2 years on study
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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 | Cognitively Unimpaired | Results of most recent testing with the source cohort indicate the participant is cognitively unimpaired as judged by consensus or expert review. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Visual Disturbance | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Bendlin, PhD, MA | UW School of Medicine and Public Health | (608) 265-2483 | bbb@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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2024 | Aug 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2023 | Aug 9, 2024 | ICF_001.pdf |
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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 |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| MRI Scan |
| Device |
MRI exams will be performed using a 3T MRI scanner, scan duration is typically 60 minutes |
|
|
| PET Scan | Device | PET imaging may be collected using either a PET scanner or a PET/Computed Tomography (CT) scanner, a PET scan will be initiated with the injection of radiotracer |
|
|
Baseline diagnosis (CU vs MCI/probable AD dementia) group differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Participants' synaptic density was examined as a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that impaired participants decreased in synaptic density more quickly and a positive number would mean that the impaired participants decreased less quickly. |
| baseline and 2 years |
| Amyloid Positivity Status Differences in Annual Rate of Change in UCB-J DVR | Amyloid positivity status differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Amyloid positivity status will be determined from amyloid PET. Participants' synaptic density was examined in a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that amyloid positive participants decreased in synaptic density more quickly and a positive number would mean that the amyloid positive participants decreased less quickly. | baseline and 2 years |
| Tau Positivity Status Differences in Annual Rate of Change in UCB-J DVR | Tau positivity status differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Tau positivity status will be determined from tau PET. Participants' synaptic density was examined as a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that tau positive participants decreased in synaptic density more quickly and a positive number would mean that the tau positive participants decreased less quickly. | baseline and 2 years |
| MTL UCB-J DVR Baseline Differences in a Cognitive Performance Age Slope in Non-demented Participants | Linear mixed effects will be used to model cognitively unimpaired participants' memory performance as a function of their age and synaptic density. Specifically, investigators will test whether those with higher synaptic density had less deterioration over time. Memory performance will be assessed using Rey Auditory Verbal Learning Test Delayed Recall. An interaction was tested, and a negative number means that those with higher synaptic density decreased faster over time, and a positive number means that they decreased slower over time. | baseline and 2 years |
| baseline |
| Difference Between ROC AUCs (MCI/AD vs CU) for MTL UCB-J DVR and Cerebrospinal Fluid (CSF) Total-tau (T-tau) | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the cerebrospinal fluid (CSF) T-tau ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, CSF T-tau. | baseline |
| Difference Between ROC AUCs (MCI/AD vs CU) for MTL UCB-J and CSF Neurogranin | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the cerebrospinal fluid (CSF) neurogranin ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, CSF neurogranin. | baseline |
| Sex Differences in Annual Rate of Change in UCB-J DVR | Sex differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Sex determined from self report. Participants' synaptic density was examined in a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that male participants decreased in synaptic density more quickly and a positive number would mean that the male participants decreased less quickly. | baseline and 2 years |
| Age Differences in Annual Rate of Change in UCB-J DVR | Linear mixed effects will be used to model all participants' UCB-J DVR trajectories as a function of their baseline age. Specifically, investigators will test whether those who were older at baseline had more deterioration over time. An interaction was tested, and a negative number means that those who were older at baseline decreased faster over time, and a positive number means that they decreased slower over time. | baseline and 2 years |
| APOE4 Allele Status Differences in Annual Rate of Change in UCB-J DVR | APOE4 allele status differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. APOE4 allele status determined from genetic testing. Participants' synaptic density was examined in a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that APOE4 positive participants decreased in synaptic density more quickly and a positive number would mean that the APOE4 positive participants decreased less quickly. | baseline and 2 years |
Abnormal cognitive status of MCI and Dementia as judged by consensus or expert review using National Institute of Aging and Alzheimer's Association (NIA-AA) 2018 criteria.
| 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 |
|
| Cognitive Impairment | Not applicable to this group | Count of Participants | Participants |
|
| OG001 | Hippocampal Volume | Hippocampal volume across all participants |
|
|
|
| Primary | ROC AUCs (MCI/AD vs CU) for MTL UCB-J and Hippocampal Cingulum Neurite Density Index | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the hippocampal cingulum neurite density index ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, hippocampal cingulum neurite density index. | Usable data on 79 participants (due to processing) | Posted | Number | 95% Confidence Interval | probability | Baseline |
|
|
|
|
| Primary | Annual Rate of Change in UCB-J DVR | Linear mixed effects regression will model UCB-J distribution volume ratio (DVR) as a function of time since baseline. 11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density. Participants' synaptic density was examined as a change per year. A positive number would mean an increase in synaptic density, a negative number means a decrease. | N = 25 contributing to the time estimate | Posted | Number | 95% Confidence Interval | distribution volume ratio per year | Baseline and 2 years |
|
|
|
|
| Primary | Baseline Diagnosis Group Differences in Annual Rate of Change in UCB-J DVR | Baseline diagnosis (CU vs MCI/probable AD dementia) group differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Participants' synaptic density was examined as a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that impaired participants decreased in synaptic density more quickly and a positive number would mean that the impaired participants decreased less quickly. | While 100 participants were enrolled in the study and entered into the model, 25 participants were measured at follow up and contributed to the time estimate; among those 25, 7 cognitively impaired and 18 unimpaired. | Posted | Number | 95% Confidence Interval | distribution volume ratio per year | baseline and 2 years |
|
|
|
| Primary | Amyloid Positivity Status Differences in Annual Rate of Change in UCB-J DVR | Amyloid positivity status differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Amyloid positivity status will be determined from amyloid PET. Participants' synaptic density was examined in a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that amyloid positive participants decreased in synaptic density more quickly and a positive number would mean that the amyloid positive participants decreased less quickly. | 90 people contributed to the overall model, 24 participants contributed to the time estimate; 3 Amyloid positive, 21 Amyloid negative, centiloid values for amyloid scans unavailable for 10 participants (unable to process) | Posted | Number | 95% Confidence Interval | distribution volume ratio per year | baseline and 2 years |
|
|
|
| Primary | Tau Positivity Status Differences in Annual Rate of Change in UCB-J DVR | Tau positivity status differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Tau positivity status will be determined from tau PET. Participants' synaptic density was examined as a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that tau positive participants decreased in synaptic density more quickly and a positive number would mean that the tau positive participants decreased less quickly. | While 94 participants were included in the model, 24 participants contributed to the time estimate; 1 Tau positive, 23 Tau negative, tau status unavailable for 6 participants, no data available for Tau scan. | Posted | Number | 95% Confidence Interval | distribution volume ratio per year | baseline and 2 years |
|
|
|
| Primary | MTL UCB-J DVR Baseline Differences in a Cognitive Performance Age Slope in Non-demented Participants | Linear mixed effects will be used to model cognitively unimpaired participants' memory performance as a function of their age and synaptic density. Specifically, investigators will test whether those with higher synaptic density had less deterioration over time. Memory performance will be assessed using Rey Auditory Verbal Learning Test Delayed Recall. An interaction was tested, and a negative number means that those with higher synaptic density decreased faster over time, and a positive number means that they decreased slower over time. | Posted | Number | 95% Confidence Interval | diff in rate of change AVLT per year | baseline and 2 years |
|
|
|
|
| Secondary | Difference Between ROC AUCs (MCI/AD vs CU) for Medial Temporal Lobe (MTL) UCB-J Distribution Volume Ratio (DVR) and Cerebrospinal Fluid (CSF) Neurofilament Light Chain Protein (NfL) | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the cerebrospinal fluid (CSF) neurofilament light chain protein (NfL) ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, CSF NfL. | Posted | Number | 95% Confidence Interval | probability | baseline |
|
|
|
|
| Secondary | Difference Between ROC AUCs (MCI/AD vs CU) for MTL UCB-J DVR and Cerebrospinal Fluid (CSF) Total-tau (T-tau) | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the cerebrospinal fluid (CSF) T-tau ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, CSF T-tau. | Posted | Number | 95% Confidence Interval | probability | baseline |
|
|
|
|
| Secondary | Difference Between ROC AUCs (MCI/AD vs CU) for MTL UCB-J and CSF Neurogranin | DeLong's method will test whether the MTL UCB-J ROC AUC has better MCI/AD prediction accuracy than the cerebrospinal fluid (CSF) neurogranin ROC AUC. ROC AUC is a measure of the correctness of group (where group is MCI/AD and cognitively unimpaired) classification using a continuous predictor, in this case, the medial temporal lobe UCB-J uptake (11C-UCB-J is a PET tracer for imaging the synaptic vesicle glycoprotein 2A in the human brain. It is considered a measure of synaptic density). This ROC AUC was compared to that of the comparator continuous predictor, CSF neurogranin. | Posted | Number | 95% Confidence Interval | probability | baseline |
|
|
|
|
| Secondary | Sex Differences in Annual Rate of Change in UCB-J DVR | Sex differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. Sex determined from self report. Participants' synaptic density was examined in a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that male participants decreased in synaptic density more quickly and a positive number would mean that the male participants decreased less quickly. | Posted | Number | 95% Confidence Interval | distribution volume ratio per year | baseline and 2 years |
|
|
|
| Secondary | Age Differences in Annual Rate of Change in UCB-J DVR | Linear mixed effects will be used to model all participants' UCB-J DVR trajectories as a function of their baseline age. Specifically, investigators will test whether those who were older at baseline had more deterioration over time. An interaction was tested, and a negative number means that those who were older at baseline decreased faster over time, and a positive number means that they decreased slower over time. | Posted | Number | 95% Confidence Interval | diff in rate of change UCB-J DVR / year | baseline and 2 years |
|
|
|
|
| Secondary | APOE4 Allele Status Differences in Annual Rate of Change in UCB-J DVR | APOE4 allele status differences in rate of UCB-J DVR change will be estimated via group x time interaction term in a linear mixed effects model. APOE4 allele status determined from genetic testing. Participants' synaptic density was examined in a change per year. The difference in the rate of change in the two groups was estimated. A negative number means that APOE4 positive participants decreased in synaptic density more quickly and a positive number would mean that the APOE4 positive participants decreased less quickly. | Posted | Number | 95% Confidence Interval | distribution volume ratio per year | baseline and 2 years |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 21 |
| 65 |
| EG001 | Cognitively Impaired | Abnormal cognitive status of MCI or dementia as judged by consensus or expert review using National Institute of Aging and Alzheimer's Association (NIA-AA) 2018 criteria. | 3 | 35 | 0 | 35 | 5 | 35 |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Memory Impairment | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Brain Fog | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Urinary Urgency | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Scab on Back of Head | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Malaise | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Muscle Cramp | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| "Fizzies" in both legs | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Presyncopy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Scalp Pain | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Coolness | General disorders | CTCAE (5.0) | Non-systematic Assessment | "coolness" energy travelling up both sides of face up to temples |
|
| Confusion and Headache | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment | disoriented on drive home and mild headache |
|
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anosmia | General disorders | CTCAE (5.0) | Non-systematic Assessment | smelled something odd |
|
Not provided
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014055 |
| Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|