Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Positron Emission Tomography (PET), PET Images
Brief summary
To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting \[18F\]flutemetamol Positron Emission Tomography (PET) Images.
Interventions
No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq. * The subject was classified as one of the following: 1. End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status. 2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status. 3. Elderly healthy volunteer (age ≥55). 4. Young healthy volunteer (age ≤40). 5. Subject with probable Alzheimer Disease (pAD). 6. Subject with amnestic Mild Cognitive Impairment (aMCI).
Exclusion criteria
* Not Applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Post flutemetamol administration | Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque. |
| Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Post flutemetamol administration | Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Reader Agreement of PET Images Without Anatomic Images | Post Flutemetamol Injection | Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study. |
Participant flow
Recruitment details
This study examined brain PET scans from 276 subjects previously acquired form various GE Healthcare studies (GE-067. The study did not enroll the blinded image Readers.
Participants by arm
| Arm | Count |
|---|---|
| [18F]Flutemetamol No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images. | 276 |
| Total | 276 |
Baseline characteristics
| Characteristic | [18F]Flutemetamol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 195 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants |
| Age, Continuous | 68.2 years STANDARD_DEVIATION 17.1 |
| Region of Enrollment Belgium | 66 participants |
| Region of Enrollment Denmark | 12 participants |
| Region of Enrollment Finland | 37 participants |
| Region of Enrollment Japan | 16 participants |
| Region of Enrollment Sweden | 3 participants |
| Region of Enrollment United Kingdom | 24 participants |
| Region of Enrollment United States | 118 participants |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 140 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
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.
Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.
Time frame: Post flutemetamol administration
Population: Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sensitivity % | Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 1 | 94 Percentage (True Positive) |
| Sensitivity % | Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 2 | 92 Percentage (True Positive) |
| Sensitivity % | Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 3 | 90 Percentage (True Positive) |
| Sensitivity % | Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 4 | 94 Percentage (True Positive) |
| Sensitivity % | Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 5 | 84 Percentage (True Positive) |
| Sensitivity % | Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Majority Read | 94 Percentage (True Positive) |
Primary
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.
Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.
Time frame: Post flutemetamol administration
Population: Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sensitivity % | Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 1 | 79 Percentage (True Negative) |
| Sensitivity % | Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 2 | 81 Percentage (True Negative) |
| Sensitivity % | Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 3 | 93 Percentage (True Negative) |
| Sensitivity % | Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 4 | 77 Percentage (True Negative) |
| Sensitivity % | Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Reader 5 | 96 Percentage (True Negative) |
| Sensitivity % | Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Majority Read | 92 Percentage (True Negative) |
Secondary
Inter-Reader Agreement of PET Images Without Anatomic Images
Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.
Time frame: Post Flutemetamol Injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 1 vs Reader 2 | 248 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 1 vs Reader 3 | 257 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 1 vs Reader 4 | 242 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 1 vs Reader 5 | 251 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 2 vs Reader 3 | 255 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 2 vs Reader 4 | 250 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 2 vs Reader 5 | 251 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 3 vs Reader 4 | 253 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 3 vs Reader 5 | 268 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Reader 4 vs Reader 5 | 245 Number of inter-reader agreements |
| Sensitivity % | Inter-Reader Agreement of PET Images Without Anatomic Images | Readers 1,2,3,4,5 | 223 Number of inter-reader agreements |