Normal Pressure Hydrocephalus
Conditions
Keywords
Amyloid, NPH Normal pressure hydrocephalus, PET Positron Emission Tomography, SUVR Standard uptake value ratios
Brief summary
This study will determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).
Interventions
All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).
Sponsors
i3 Statprobe
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is 50 years old or older. * The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid. * Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.
Exclusion criteria
* The subject has a contraindication for MRI or PET. * The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol. * The subject has participated in any clinical study using an investigational agent within 30 days of dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Post-contrast administration | Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV\_voi/SUV\_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV\_voi) or reference region (SUV\_ref). VOI means volume of interest and REF means reference region. |
| Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | Post-contrast administration | This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Post-contrast Administration | Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \[18F\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flutemetamol Injection \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels(MBq). | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Flutemetamol Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 70 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.
This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.
Time frame: Post-contrast administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subject 201-0001 | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | 0.127 Percent plaque area |
| Subject 201-0002 | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | 0.447 Percent plaque area |
| Subject 201-0003 | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | 0 Percent plaque area |
| Subject 201-0004 | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | 1.007 Percent plaque area |
| Subject 201-0005 | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | 0.4 Percent plaque area |
| Subject 201-0006 | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | 0 Percent plaque area |
| Subject 201-0007 | Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. | 0 Percent plaque area |
Primary
Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.
Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV\_voi/SUV\_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV\_voi) or reference region (SUV\_ref). VOI means volume of interest and REF means reference region.
Time frame: Post-contrast administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Posterior Cortex | 2.11 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-VOI surrounding biopsy | 1.59 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Composite VOI | 2.13 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Lateral Temporal Cortex | 2.08 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Contralateral biopsy | 1.77 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Frontal Cortex | 2.24 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Anterior Cingulate | 2.19 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0001 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Parietal Cortex | 1.99 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Composite VOI | 2.48 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-VOI surrounding biopsy | 1.56 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Posterior Cortex | 2.33 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Anterior Cingulate | 2.36 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Parietal Cortex | 2.38 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Contralateral biopsy | 1.93 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Frontal Cortex | 2.78 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0002 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Lateral Temporal Cortex | 2.35 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Composite VOI | 1.39 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Parietal Cortex | 1.38 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-VOI surrounding biopsy | 1.25 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Anterior Cingulate | 1.44 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Lateral Temporal Cortex | 1.45 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Contralateral biopsy | 1.16 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Frontal Cortex | 1.32 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0003 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Posterior Cortex | 1.40 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Frontal Cortex | 2.71 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Lateral Temporal Cortex | 2.56 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-VOI surrounding biopsy | 2.17 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Contralateral biopsy | 2.32 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Anterior Cingulate | 2.81 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Posterior Cortex | 2.86 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Parietal Cortex | 2.84 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0004 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Composite VOI | 2.74 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Parietal Cortex | 2.27 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Composite VOI | 2.62 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Posterior Cortex | 2.73 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Anterior Cingulate | 2.65 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Frontal Cortex | 2.74 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Lateral Temporal Cortex | 2.63 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-VOI surrounding biopsy | 2.07 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0005 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Contralateral biopsy | 2.08 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-VOI surrounding biopsy | 1.39 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Parietal Cortex | 1.36 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Frontal Cortex | 1.28 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Anterior Cingulate | 1.26 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Posterior Cortex | 1.17 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Composite VOI | 1.34 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Lateral Temporal Cortex | 1.52 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0006 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Contralateral biopsy | 1.18 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Composite VOI | 1.34 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Parietal Cortex | 1.35 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Posterior Cortex | 1.73 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Anterior Cingulate | 1.27 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Frontal Cortex | 1.19 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-VOI surrounding biopsy | 1.00 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Contralateral biopsy | 0.86 Standard Uptake Value Ratio (SUVR) |
| Subject 201-0007 | Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. | Brain Region-Cerebellum-Lateral Temporal Cortex | 1.32 Standard Uptake Value Ratio (SUVR) |
Secondary
Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \[18F\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.
Time frame: Post-contrast Administration
Population: Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \[18F\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subject 201-0001 | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Subject-201-0001 | 0.127 Percentage of Plaque |
| Subject 201-0001 | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Subject-201-0002 | 0.447 Percentage of Plaque |
| Subject 201-0001 | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Subject-201-0003 | 0 Percentage of Plaque |
| Subject 201-0001 | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Subject-201-0004 | 1.007 Percentage of Plaque |
| Subject 201-0001 | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Subject-201-0005 | 0.4 Percentage of Plaque |
| Subject 201-0001 | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Subject-201-0006 | 0 Percentage of Plaque |
| Subject 201-0001 | Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects | Subject-201-0007 | 0 Percentage of Plaque |
Comparison: Contralateral to the biopsy Sitep-value: 0.098Regression, Linear
Comparison: Ipsilateral to the biopsy Sitep-value: 0.268Regression, Linear
Comparison: Composite Regionp-value: 0.099Regression, Linear