Cognitive Impairment
Conditions
Brief summary
Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.
Interventions
None listed
Sponsors
Covance
H2O Clinical LLC
GE Healthcare
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject was enrolled in prior Study GE067-007. * The subject died on or before 10 June 2013. * The subject's brain is judged to be of suitable quality for analysis, including all regions necessary for analysis.
Exclusion criteria
* Not Applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Abnormal Blinded Visual PET Image Interpretations. | Brain images will be assessed up to 1 year post subject's death. | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program. |
| Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Brain images will be assessed up to 1 year post subject's death. | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Blinded Visual PET Image Interpretations | Brain images will be assessed up to 1 year post subject's death. | Specificity of blinded visual image interpretations according to neuropathological criteria. |
| Specificity Percentage of Blinded Visual PET Image Interpretations | Brain images will be assessed up to 1 year post subject's death. | Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain. |
Countries
United States
Participant flow
Recruitment details
This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
Participants by arm
| Arm | Count |
|---|---|
| Flutemetamol (18F) There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | no evaluable Standard of Truth results | 2 |
Baseline characteristics
| Characteristic | Flutemetamol (18F) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 98 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 80.8 years STANDARD_DEVIATION 8.87 |
| Region of Enrollment United Kingdom | 4 participants |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans
Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.
Time frame: Brain images will be assessed up to 1 year post subject's death.
Population: There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Truth (SoT) | Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Reader 1-Blinded Visual--Abnormal Interpretation | 96.1 Percent of Sensitivity |
| Standard of Truth (SoT) | Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Reader 2-Blinded Visual--Abnormal Interpretation | 89.5 Percent of Sensitivity |
| Standard of Truth (SoT) | Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Reader 3-Blinded Visual--Abnormal Interpretation | 88.2 Percent of Sensitivity |
| Standard of Truth (SoT) | Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Reader 4-Blinded Visual--Abnormal Interpretation | 88.2 Percent of Sensitivity |
| Standard of Truth (SoT) | Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Reader 5-Blinded Visual--Abnormal Interpretation | 94.7 Percent of Sensitivity |
| Standard of Truth (SoT) | Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Majority Read-Abnormal | 90.8 Percent of Sensitivity |
Primary
The Number of Abnormal Blinded Visual PET Image Interpretations.
Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.
Time frame: Brain images will be assessed up to 1 year post subject's death.
Population: There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Truth (SoT) | The Number of Abnormal Blinded Visual PET Image Interpretations. | Reader 1-Blinded Visual--Abnormal Interpretation | 73 Number of Blinded Image Interpretations |
| Standard of Truth (SoT) | The Number of Abnormal Blinded Visual PET Image Interpretations. | Reader 2-Blinded Visual--Abnormal Interpretation | 68 Number of Blinded Image Interpretations |
| Standard of Truth (SoT) | The Number of Abnormal Blinded Visual PET Image Interpretations. | Reader 3-Blinded Visual--Abnormal Interpretation | 67 Number of Blinded Image Interpretations |
| Standard of Truth (SoT) | The Number of Abnormal Blinded Visual PET Image Interpretations. | Reader 4-Blinded Visual--Abnormal Interpretation | 67 Number of Blinded Image Interpretations |
| Standard of Truth (SoT) | The Number of Abnormal Blinded Visual PET Image Interpretations. | Reader 5-Blinded Visual--Abnormal Interpretation | 72 Number of Blinded Image Interpretations |
| Standard of Truth (SoT) | The Number of Abnormal Blinded Visual PET Image Interpretations. | Majority Read-Abnormal | 69 Number of Blinded Image Interpretations |
Secondary
Number of Blinded Visual PET Image Interpretations
Specificity of blinded visual image interpretations according to neuropathological criteria.
Time frame: Brain images will be assessed up to 1 year post subject's death.
Population: There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Truth (SoT) | Number of Blinded Visual PET Image Interpretations | Reader 1-Blinded Visual-Normal Interpretation | 25 Number of Blinded Image Intrepretations |
| Standard of Truth (SoT) | Number of Blinded Visual PET Image Interpretations | Reader 2-Blinded Visual-Normal Interpretation | 27 Number of Blinded Image Intrepretations |
| Standard of Truth (SoT) | Number of Blinded Visual PET Image Interpretations | Reader 3-Blinded Visual-Normal Interpretation | 28 Number of Blinded Image Intrepretations |
| Standard of Truth (SoT) | Number of Blinded Visual PET Image Interpretations | Reader 4-Blinded Visual-Normal Interpretation | 25 Number of Blinded Image Intrepretations |
| Standard of Truth (SoT) | Number of Blinded Visual PET Image Interpretations | Reader 5-Blinded Visual-Normal Interpretation | 26 Number of Blinded Image Intrepretations |
| Standard of Truth (SoT) | Number of Blinded Visual PET Image Interpretations | Majority Read-Normal | 27 Number of Blinded Image Intrepretations |
Secondary
Specificity Percentage of Blinded Visual PET Image Interpretations
Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.
Time frame: Brain images will be assessed up to 1 year post subject's death.
Population: There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Truth (SoT) | Specificity Percentage of Blinded Visual PET Image Interpretations | Reader 1-Blinded Visual-Normal Interpretation | 83.3 Percentage of Specificity |
| Standard of Truth (SoT) | Specificity Percentage of Blinded Visual PET Image Interpretations | Reader 2-Blinded Visual-Normal Interpretation | 90.0 Percentage of Specificity |
| Standard of Truth (SoT) | Specificity Percentage of Blinded Visual PET Image Interpretations | Reader 3-Blinded Visual-Normal Interpretation | 93.3 Percentage of Specificity |
| Standard of Truth (SoT) | Specificity Percentage of Blinded Visual PET Image Interpretations | Reader 4-Blinded Visual-Normal Interpretation | 83.3 Percentage of Specificity |
| Standard of Truth (SoT) | Specificity Percentage of Blinded Visual PET Image Interpretations | Reader 5-Blinded Visual-Normal Interpretation | 86.7 Percentage of Specificity |
| Standard of Truth (SoT) | Specificity Percentage of Blinded Visual PET Image Interpretations | Majority Read-Normal | 90.0 Percentage of Specificity |