Trial Outcomes & Findings for PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus (NCT NCT01053312)
NCT ID: NCT01053312
Last Updated: 2012-06-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Post-contrast administration
Results posted on
2012-06-11
Participant Flow
Participant milestones
| Measure |
Flutemetamol Injection
\[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels(MBq).
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
Baseline characteristics by cohort
| Measure |
Flutemetamol Injection
n=7 Participants
\[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels(MBq).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=93 Participants
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Age, Categorical
>=65 years
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6 Participants
n=93 Participants
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Age Continuous
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70 years
STANDARD_DEVIATION 8.7 • n=93 Participants
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Sex: Female, Male
Female
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3 Participants
n=93 Participants
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Sex: Female, Male
Male
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4 Participants
n=93 Participants
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Region of Enrollment
United States
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7 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Post-contrast administrationRadiotracers 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.
Outcome measures
| Measure |
Subject 201-0001
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0002
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0003
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0004
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0005
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0006
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0007
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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|---|---|---|---|---|---|---|---|
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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
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1.59 Standard Uptake Value Ratio (SUVR)
|
1.56 Standard Uptake Value Ratio (SUVR)
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1.25 Standard Uptake Value Ratio (SUVR)
|
2.17 Standard Uptake Value Ratio (SUVR)
|
2.07 Standard Uptake Value Ratio (SUVR)
|
1.39 Standard Uptake Value Ratio (SUVR)
|
1.00 Standard Uptake Value Ratio (SUVR)
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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
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1.77 Standard Uptake Value Ratio (SUVR)
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1.93 Standard Uptake Value Ratio (SUVR)
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1.16 Standard Uptake Value Ratio (SUVR)
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2.32 Standard Uptake Value Ratio (SUVR)
|
2.08 Standard Uptake Value Ratio (SUVR)
|
1.18 Standard Uptake Value Ratio (SUVR)
|
0.86 Standard Uptake Value Ratio (SUVR)
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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
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2.19 Standard Uptake Value Ratio (SUVR)
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2.36 Standard Uptake Value Ratio (SUVR)
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1.44 Standard Uptake Value Ratio (SUVR)
|
2.81 Standard Uptake Value Ratio (SUVR)
|
2.65 Standard Uptake Value Ratio (SUVR)
|
1.26 Standard Uptake Value Ratio (SUVR)
|
1.27 Standard Uptake Value Ratio (SUVR)
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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
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2.24 Standard Uptake Value Ratio (SUVR)
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2.78 Standard Uptake Value Ratio (SUVR)
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1.32 Standard Uptake Value Ratio (SUVR)
|
2.71 Standard Uptake Value Ratio (SUVR)
|
2.74 Standard Uptake Value Ratio (SUVR)
|
1.28 Standard Uptake Value Ratio (SUVR)
|
1.19 Standard Uptake Value Ratio (SUVR)
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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
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2.08 Standard Uptake Value Ratio (SUVR)
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2.35 Standard Uptake Value Ratio (SUVR)
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1.45 Standard Uptake Value Ratio (SUVR)
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2.56 Standard Uptake Value Ratio (SUVR)
|
2.63 Standard Uptake Value Ratio (SUVR)
|
1.52 Standard Uptake Value Ratio (SUVR)
|
1.32 Standard Uptake Value Ratio (SUVR)
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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
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1.99 Standard Uptake Value Ratio (SUVR)
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2.38 Standard Uptake Value Ratio (SUVR)
|
1.38 Standard Uptake Value Ratio (SUVR)
|
2.84 Standard Uptake Value Ratio (SUVR)
|
2.27 Standard Uptake Value Ratio (SUVR)
|
1.36 Standard Uptake Value Ratio (SUVR)
|
1.35 Standard Uptake Value Ratio (SUVR)
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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
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2.11 Standard Uptake Value Ratio (SUVR)
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2.33 Standard Uptake Value Ratio (SUVR)
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1.40 Standard Uptake Value Ratio (SUVR)
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2.86 Standard Uptake Value Ratio (SUVR)
|
2.73 Standard Uptake Value Ratio (SUVR)
|
1.17 Standard Uptake Value Ratio (SUVR)
|
1.73 Standard Uptake Value Ratio (SUVR)
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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
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2.13 Standard Uptake Value Ratio (SUVR)
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2.48 Standard Uptake Value Ratio (SUVR)
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1.39 Standard Uptake Value Ratio (SUVR)
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2.74 Standard Uptake Value Ratio (SUVR)
|
2.62 Standard Uptake Value Ratio (SUVR)
|
1.34 Standard Uptake Value Ratio (SUVR)
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1.34 Standard Uptake Value Ratio (SUVR)
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PRIMARY outcome
Timeframe: Post-contrast administrationThis 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.
Outcome measures
| Measure |
Subject 201-0001
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0002
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0003
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0004
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0005
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0006
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0007
n=1 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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|---|---|---|---|---|---|---|---|
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Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.
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0.127 Percent plaque area
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0.447 Percent plaque area
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0 Percent plaque area
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1.007 Percent plaque area
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0.4 Percent plaque area
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0 Percent plaque area
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0 Percent plaque area
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SECONDARY outcome
Timeframe: Post-contrast AdministrationPopulation: 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.
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.
Outcome measures
| Measure |
Subject 201-0001
n=7 Participants
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0002
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0003
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0004
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0005
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0006
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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Subject 201-0007
\[18F\]flutemetamol Injection-less than 10µg of flutemetamol.
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|---|---|---|---|---|---|---|---|
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Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Subject-201-0001
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0.127 Percentage of Plaque
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—
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—
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—
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—
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—
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—
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Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Subject-201-0002
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0.447 Percentage of Plaque
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—
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—
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—
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—
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—
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—
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Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Subject-201-0003
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0 Percentage of Plaque
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—
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—
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—
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—
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—
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—
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Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Subject-201-0004
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1.007 Percentage of Plaque
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—
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—
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—
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—
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—
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—
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Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Subject-201-0005
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0.4 Percentage of Plaque
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—
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—
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—
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—
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—
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—
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Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Subject-201-0006
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0 Percentage of Plaque
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—
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—
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—
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—
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—
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—
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Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
Subject-201-0007
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0 Percentage of Plaque
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—
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—
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—
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—
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—
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—
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Adverse Events
Flutemetamol Injection
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flutemetamol Injection
n=7 participants at risk
\[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels(MBq).
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|---|---|
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Investigations
Blood Pressure Increase
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71.4%
5/7 • Number of events 5
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Investigations
Blood Glucose Decrease
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14.3%
1/7 • Number of events 1
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Investigations
Dizziness
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14.3%
1/7 • Number of events 1
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Vascular disorders
Flushing
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14.3%
1/7 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place