Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autopsy Cohort | Experimental | End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir F18. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie [mCi]) of flortaucipir. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | autopsy within 6 months of scan |
| Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | autopsy within 6 months of scan |
| Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | autopsy within 6 months of scan |
| Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34933123 | Background | Ushizima D, Chen Y, Alegro M, Ovando D, Eser R, Lee W, Poon K, Shankar A, Kantamneni N, Satrawada S, Junior EA, Heinsen H, Tosun D, Grinberg LT. Deep learning for Alzheimer's disease: Mapping large-scale histological tau protein for neuroimaging biomarker validation. Neuroimage. 2022 Mar;248:118790. doi: 10.1016/j.neuroimage.2021.118790. Epub 2021 Dec 20. |
Not provided
Not provided
To be considered eligible for the primary analysis, death had to occur within 6 months of flortaucipir scan and valid autopsy was required.
Enrollment was opened in June 2015 and closed in May 2018. First patient enrolled in November 2016 and last enrolled patient completed the study procedures in June 2017. Study enrolled end-of-life subjects (life expectancy less than 6 months) at medical centers in the US who consented to a flortaucipir PET scan and to brain donation at autopsy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Cohort | End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects consenting to flortaucipir PET and brain donation at autopsy
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Cohort | End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir. |
| 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 | Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | One subject did not come to autopsy within 6 months of the flortaucipir scan. | Posted | Number | Correlation coefficient | autopsy within 6 months of scan |
|
Up to a total of 6 months
Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Analysis Cohort | End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir. |
Not provided
Not provided
The original intent of the protocol was to assess relationships between in vivo flortaucipir PET signal and tau pathology at a higher resolution than the Free Surfer ROIs, such as voxel-wise. Higher resolution could potentially offer more precise insights into tracer distribution patterns. However, the analysis was constrained by challenges in acquiring a complete set of pathology images from collaborators and unanticipated technical challenges in image processing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | AVD_Clinical_Ops@lists.lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2016 | Mar 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2024 | Apr 17, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. |
| autopsy within 6 months of scan |
| Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | autopsy within 6 months of scan |
| Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | autopsy within 6 months of scan |
| Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | autopsy within 6 months of scan |
| San Francisco |
| California |
| 94121 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Mini Mental Status Exam (MMSE) Score | MMSE is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment. | n=2 for cognitively impaired subjects. Cognitively normal subject mental status was not measured. | Mean | Standard Deviation | units on a scale |
|
| Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Score | IQCODE is short questionnaire designed to assess cognitive decline and dementia in elderly people. The questionnaire is filled out by a relative or friend who has known the elderly person for 10 years or more. The result is a score that ranges from 1 to 5. A score of 3 means that the subject is rated on average as 'no change'. A score of 4 means an average of 'a bit worse'. A score of 5 an average of 'much worse'. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Primary | Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | One subject did not come to autopsy within 6 months of the flortaucipir scan. | Posted | Number | Correlation coefficient | autopsy within 6 months of scan |
|
|
|
|
| Primary | Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | One subject did not come to autopsy within 6 months of the flortaucipir scan. | Posted | Number | Correlation coefficient | autopsy within 6 months of scan |
|
|
|
|
| Primary | Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | One subject did not come to autopsy within 6 months of the flortaucipir scan. | Posted | Number | Correlation coefficient | autopsy within 6 months of scan |
|
|
|
|
| Primary | Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | One subject did not come to autopsy within 6 months of the flortaucipir scan. | Posted | Number | Correlation coefficient | autopsy within 6 months of scan |
|
|
|
|
| Primary | Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | One subject did not come to autopsy within 6 months of the flortaucipir scan. | Posted | Number | Correlation coefficient | autopsy within 6 months of scan |
|
|
|
|
| Primary | Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region | Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | One subject did not come to autopsy within 6 months of the flortaucipir scan. | Posted | Number | Correlation coefficient | autopsy within 6 months of scan |
|
|
|
|
| 2 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |