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This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amyloid Negative Subjects | Experimental | Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB. |
|
| Amyloid Positive Subjects | Experimental | Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetapir (18F) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Florbetapir SUVr Conversion to Centiloid Units | Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure. | up to 70 minutes post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid | Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure. |
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Inclusion Criteria:
Cognitively Normal Subjects
Clinically Diagnosed AD Subject
Possible AD Subject
MCI Subject
At Risk Elderly Subject
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25443857 | Background | Klunk WE, Koeppe RA, Price JC, Benzinger TL, Devous MD Sr, Jagust WJ, Johnson KA, Mathis CA, Minhas D, Pontecorvo MJ, Rowe CC, Skovronsky DM, Mintun MA. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015 Jan;11(1):1-15.e1-4. doi: 10.1016/j.jalz.2014.07.003. Epub 2014 Oct 28. |
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First subject enrolled: 14 April 2014; Last subject completed: 18 September 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Clincally Diagnosed AD | Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD) |
| FG001 | Possible AD | Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease |
| FG002 | Mild Cognitive Impairment (MCI) | Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater |
| FG003 | At Risk Elderly | Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal |
| FG004 | Young Healthy Controls (YHC) | Cognitively normal young subjects between 21 and 45 years of age (inclusive) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects receiving at least one dose of florbetapir
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| ID | Title | Description |
|---|---|---|
| BG000 | Clincally Diagnosed AD | Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD) |
| BG001 | Possible AD | Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease |
| 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 | Florbetapir SUVr Conversion to Centiloid Units | Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure. | All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete a florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan. | Posted | Mean | Standard Deviation | centiloid | up to 70 minutes post injection |
|
within 48 hours of scan as noted by group title
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Florbetapir Only | Events occurring within 48 hours following florbetapir scans only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
| C475519 | 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole |
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| 11C-PiB | Drug |
|
|
| up to 70 minutes post injection |
| Variability of PET Images in Young Healthy Control Subjects. | Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure. | up to 70 minutes post injection |
| Heidelberg |
| Victoria |
| 3084 |
| Australia |
| BG002 | Mild Cognitive Impairment (MCI) | Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater |
| BG003 | At Risk Elderly | Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal |
| BG004 | Young Healthy Controls (YHC) | Cognitively normal young subjects between 21 and 45 years of age (inclusive) |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mini Mental Status Exam | Mini Mental Status Exam (MMSE) is a brief instrument used to assess cognitive function in elderly patients. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention. The maximum score for the first section is 21. The second section tests the ability of the patient to name objects, follow verbal and written commands, write a sentence, and copy figures. The maximum score for the second section is 9. The range for the total MMSE score is 0 to 30. Higher scores indicate higher cognitive function. | Mean | Standard Deviation | units on a scale |
|
Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD) |
| OG001 | Possible AD | Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease |
| OG002 | Mild Cognitive Impairment (MCI) | Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater |
| OG003 | At Risk Elderly | Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal |
| OG004 | Young Healthy Controls (YHC) | Cognitively normal young subjects between 21 and 45 years of age (inclusive) |
|
|
| Secondary | Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid | Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure. | All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete the florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan. | Posted | Mean | Standard Deviation | centiloid | up to 70 minutes post injection |
|
|
|
|
| Secondary | Variability of PET Images in Young Healthy Control Subjects. | Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure. | Young healthy controls enrolled in the study | Posted | Mean | Standard Deviation | SUVr | up to 70 minutes post injection |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | PiB Only | Events occurring within 48 hours of PiB scans only | 0 | 35 | 0 | 35 |
| EG002 | Both | Events occurring within 48 hours of both florbetapir and PiB scans | 0 | 34 | 0 | 34 |
| EG003 | Total | Events following Florbetapir (florbetapir only and both) | 0 | 34 | 0 | 34 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| 11C-PiB |
|
| 6.69 |
| 2-Sided |
| Superiority or Other |